Photodamaged Skin
Conditions
Keywords
Trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.
Brief summary
The study hypothesis is that Imedeen will show effects on skin health, when compared to placebo over a 6 month intervention period with respect to changes in skin appearance, skin density, moisture, and in fine lines and wrinkles.
Interventions
DIETARY_SUPPLEMENTImedeen
Two tablets per day for 6 months
DIETARY_SUPPLEMENTPlacebo
Two tablets per day for 6 months
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
In general good health and have no contraindications to the study product; Have Fitzpatrick Skin Type I-IV as determined by a trained evaluator. Have Glogau Classification of Photoaging of II or III as determined by the investigator.
Exclusion criteria
Use of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin within one month of baseline. History of or current disease or condition of the skin that the investigator deems inappropriate for participation (eg, atopic skin, facial scars, psoriasis, eczema, other scaly inflammatory diseases). Subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 to 9 months from baseline (pending procedure type) or plan to have a treatment during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24 | Baseline, Week 24 | IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12 | Baseline, Week 12 | IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe. |
| Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline, Week 12, 24 | Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or bags under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe. |
| Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Baseline, Week 12, 24 | Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation \[MH\]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe. |
| Participants Improvement Assessment of Face at Week 12 and 24 | Baseline, Week 12, 24 | Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration \[uneven, patchy, blotchy areas of light and dark, age spots, liver spots\], complexion/glow \[bright radiant appearance\] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement). |
| Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24 | Week 24 | IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement). |
| Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Baseline, Week 6, 12, 18, 24 | DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement). |
| Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Baseline, Week 6, 12, 18, 24 | Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm \[millimeter\] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement). |
| Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Baseline, Week 6, 12, 18, 24 | Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement). |
| Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Baseline, Week 6, 12, 18, 24 | Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement). |
| Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline, Week 12, 24 | Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. | 95 |
| Imedeen Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks. | 98 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | No longer met eligibility criteria | 1 | 0 |
| Overall Study | Protocol Violation | 3 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Placebo | Imedeen | Total |
|---|---|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 7.38 | 52.7 years STANDARD_DEVIATION 6.58 | 52.6 years STANDARD_DEVIATION 6.96 |
| Sex: Female, Male Female | 95 Participants | 98 Participants | 193 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 95 | 29 / 98 |
| serious Total, serious adverse events | 0 / 95 | 2 / 98 |
Outcome results
Primary
Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24
IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe.
Time frame: Baseline, Week 24
Population: Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24 | Baseline (n=93,97) | 6.04 units on scale | Standard Deviation 1.45 |
| Placebo | Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24 | Change at Week 24 (n=92,95) | 0.6 units on scale | Standard Deviation 1.28 |
| Imedeen | Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24 | Baseline (n=93,97) | 5.81 units on scale | Standard Deviation 1.3 |
| Imedeen | Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24 | Change at Week 24 (n=92,95) | 0.7 units on scale | Standard Deviation 1.23 |
Comparison: Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.35895% CI: [-0.16, 0.44]ANOVA
Secondary
Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24
Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation \[MH\]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe.
Time frame: Baseline, Week 12, 24
Population: Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time -points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 24: Decolletage-Crepyness (n=92,95) | 0.7 units on scale | Standard Deviation 1.56 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Baseline: Decolletage-Crepyness (n=93,97) | 4.65 units on scale | Standard Deviation 1.77 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Baseline: Decolletage-MH (n=93,97) | 5.09 units on scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Baseline: Back of Hands-Crepyness (n=93,97) | 5.37 units on scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Baseline: Back of Hands-MH (n=93,97) | 3.96 units on scale | Standard Deviation 1.53 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 12: Decolletage-Crepyness (n=92,95) | 0.2 units on scale | Standard Deviation 1.23 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 12: Decolletage-MH (n=92,95) | 0.4 units on scale | Standard Deviation 1.36 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 12:Back of Hands-Crepyness(n=92,95) | 0.6 units on scale | Standard Deviation 1.39 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 12: Back of Hands-MH (n=92,95) | -0.2 units on scale | Standard Deviation 1.09 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 24: Decolletage-MH (n=92,95) | 0.6 units on scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 24:Back of Hands-Crepyness(n=92,95) | 0.7 units on scale | Standard Deviation 1.39 |
| Placebo | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 24: Back of Hands-MH (n=92,95) | 0.1 units on scale | Standard Deviation 1.2 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 24:Back of Hands-Crepyness(n=92,95) | 0.7 units on scale | Standard Deviation 1.45 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 24: Decolletage-Crepyness (n=92,95) | 0.7 units on scale | Standard Deviation 1.36 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 12: Decolletage-MH (n=92,95) | 0.5 units on scale | Standard Deviation 1.2 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Baseline: Decolletage-Crepyness (n=93,97) | 4.56 units on scale | Standard Deviation 1.6 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 24: Decolletage-MH (n=92,95) | 0.6 units on scale | Standard Deviation 1.14 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Baseline: Decolletage-MH (n=93,97) | 5.08 units on scale | Standard Deviation 1.65 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 12:Back of Hands-Crepyness(n=92,95) | 0.5 units on scale | Standard Deviation 1.48 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Baseline: Back of Hands-Crepyness (n=93,97) | 5.19 units on scale | Standard Deviation 1.42 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 24: Back of Hands-MH (n=92,95) | 0.4 units on scale | Standard Deviation 1.22 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Baseline: Back of Hands-MH (n=93,97) | 3.92 units on scale | Standard Deviation 1.69 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 12: Back of Hands-MH (n=92,95) | 0.3 units on scale | Standard Deviation 1.08 |
| Imedeen | Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 | Change at Week 12: Decolletage-Crepyness (n=92,95) | 0.2 units on scale | Standard Deviation 1.49 |
Comparison: Change at Week 12, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.90195% CI: [-0.33, 0.37]ANOVA
Comparison: Change at Week 12, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.39995% CI: [-0.19, 0.47]ANOVA
Comparison: Change at Week 12, Back of Hands-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.87595% CI: [-0.38, 0.32]ANOVA
Comparison: Change at Week 12, Back of Hands-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.00595% CI: [0.13, 0.73]ANOVA
Comparison: Change at Week 24, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.87695% CI: [-0.33, 0.38]ANOVA
Comparison: Change at Week 24, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.78995% CI: [-0.29, 0.38]ANOVA
Comparison: Change at Week 24, Back of Hands- Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.90195% CI: [-0.31, 0.38]ANOVA
Comparison: Change at Week 24, Back of Hands - Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.02795% CI: [0.04, 0.72]ANOVA
Secondary
Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24
Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or bags under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe.
Time frame: Baseline, Week 12, 24
Population: Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: Fine L/W Perioral A(n= 92,95) | 0.4 units on scale | Standard Deviation 1.01 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: MH (n= 92,95) | 0.7 units on scale | Standard Deviation 1.32 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: Under eye dc or bags (n= 92,95) | 0.5 units on scale | Standard Deviation 1.28 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: MH (n=93,97) | 4.95 units on scale | Standard Deviation 1.71 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: MH (n= 92,95) | 0.3 units on scale | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: Fine L/W Periocular A (n=93,97) | 5.95 units on scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: Sallowness/yellowing (n= 92,95) | 0.4 units on scale | Standard Deviation 1.46 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: Fine L/W Periocular A(n= 92,95) | 0.7 units on scale | Standard Deviation 1.31 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: Sallowness/yellowing (n=93,97) | 3.41 units on scale | Standard Deviation 1.42 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: Fine L/W Perioral A(n= 92,95) | 0.4 units on scale | Standard Deviation 1.14 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: Fine L/W Perioral A (n= 93,97) | 4.89 units on scale | Standard Deviation 1.78 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: Under eye dc or bags (n= 92,95) | 0.7 units on scale | Standard Deviation 1.66 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: Roughness/texture (n=93,97) | 3.10 units on scale | Standard Deviation 1.66 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: Roughness/texture (n= 92,95) | 0.4 units on scale | Standard Deviation 1.63 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: Sallowness/yellowing (n= 92,95) | 1.0 units on scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: Fine L/W Periocular A(n= 92,95) | 0.5 units on scale | Standard Deviation 1.04 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: Roughness/texture (n= 92,95) | 0.8 units on scale | Standard Deviation 1.65 |
| Placebo | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: Under eye dc or bags(n= 93,97) | 5.68 units on scale | Standard Deviation 1.55 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: Roughness/texture (n= 92,95) | 0.5 units on scale | Standard Deviation 1.63 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: Sallowness/yellowing (n= 92,95) | 0.4 units on scale | Standard Deviation 1.45 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: Roughness/texture (n= 92,95) | 0.2 units on scale | Standard Deviation 1.45 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: Fine L/W Perioral A (n= 93,97) | 4.69 units on scale | Standard Deviation 1.65 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: Under eye dc or bags(n= 93,97) | 5.34 units on scale | Standard Deviation 1.44 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: MH (n=93,97) | 5.06 units on scale | Standard Deviation 1.51 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: Sallowness/yellowing (n=93,97) | 3.51 units on scale | Standard Deviation 1.33 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: Roughness/texture (n=93,97) | 2.77 units on scale | Standard Deviation 1.5 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: Fine L/W Periocular A(n= 92,95) | 0.5 units on scale | Standard Deviation 1.09 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: Fine L/W Perioral A(n= 92,95) | 0.4 units on scale | Standard Deviation 1.07 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: Under eye dc or bags (n= 92,95) | 0.3 units on scale | Standard Deviation 1.38 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 12: MH (n= 92,95) | 0.3 units on scale | Standard Deviation 1.42 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: Fine L/W Periocular A(n= 92,95) | 0.8 units on scale | Standard Deviation 1.26 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: Fine L/W Perioral A(n= 92,95) | 0.5 units on scale | Standard Deviation 1.09 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: Under eye dc or bags (n= 92,95) | 0.6 units on scale | Standard Deviation 1.37 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: MH (n= 92,95) | 0.7 units on scale | Standard Deviation 1.36 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Change at Week 24: Sallowness/yellowing (n= 92,95) | 1.0 units on scale | Standard Deviation 1.45 |
| Imedeen | Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 | Baseline: Fine L/W Periocular A (n=93,97) | 5.79 units on scale | Standard Deviation 1.44 |
Comparison: Change at Week 12, Fine lines/wrinkles (Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.96595% CI: [-0.29, 0.3]ANOVA
Comparison: Change at Week 12, Fine lines/wrinkles (Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.67495% CI: [-0.2, 0.3]ANOVA
Comparison: Change at Week 12, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.91695% CI: [-0.35, 0.32]ANOVA
Comparison: Change at Week 12, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.91595% CI: [-0.39, 0.35]ANOVA
Comparison: Change at Week 12, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.67295% CI: [-0.4, 0.26]ANOVA
Comparison: Change at Week 12, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.65595% CI: [-0.27, 0.43]ANOVA
Comparison: Change at Week 24, Fine lines/wrinkles(Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.56195% CI: [-0.23, 0.43]ANOVA
Comparison: Change at Week 24, Fine lines/wrinkles(Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.35695% CI: [-0.14, 0.4]ANOVA
Comparison: Change at Week 24, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.66995% CI: [-0.28, 0.43]ANOVA
Comparison: Change at Week 24, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.95495% CI: [-0.32, 0.34]ANOVA
Comparison: Change at Week 24, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.68495% CI: [-0.34, 0.22]ANOVA
Comparison: Change at Week 24, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.88695% CI: [-0.35, 0.3]ANOVA
Secondary
Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12
IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe.
Time frame: Baseline, Week 12
Population: m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12 | Baseline (n=93,97) | 6.04 units on scale | Standard Deviation 1.45 |
| Placebo | Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12 | Change at Week 12 (n=92,95) | 0.4 units on scale | Standard Deviation 1.14 |
| Imedeen | Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12 | Baseline (n=93,97) | 5.81 units on scale | Standard Deviation 1.3 |
| Imedeen | Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12 | Change at Week 12 (n=92,95) | 0.4 units on scale | Standard Deviation 1.07 |
Comparison: Change at Week 12: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.79795% CI: [-0.25, 0.33]ANOVA
Secondary
Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)
Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).
Time frame: Baseline, Week 6, 12, 18, 24
Population: m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Baseline: Left Cheek (n=58,59) | 10.5 micrometer | Standard Deviation 4.05 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 6: Left Cheek (n=57,59) | -0.1 micrometer | Standard Deviation 4.43 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 12: Left Cheek (n=54,55) | -0.1 micrometer | Standard Deviation 4.49 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 18: Left Cheek (n=49,52) | -1.8 micrometer | Standard Deviation 5.68 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 24: Left Cheek (n=49,53) | -2.5 micrometer | Standard Deviation 5.68 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Baseline: Left Inner Arm (n=58,58) | 28.0 micrometer | Standard Deviation 6.96 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 6: Left Inner Arm (n=57,58) | -1.0 micrometer | Standard Deviation 10.2 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 12: Left Inner Arm (n=54,54) | 0.3 micrometer | Standard Deviation 8.73 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 18: Left Inner Arm (n=49,50) | -4.5 micrometer | Standard Deviation 10.73 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 24: Left Inner Arm (n=49,52) | -6.6 micrometer | Standard Deviation 10.98 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Baseline: Left Outer Arm (n=58,58) | 19.5 micrometer | Standard Deviation 5.82 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 12: Left Outer Arm (n=54,54) | -0.5 micrometer | Standard Deviation 6.61 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 18: Left Outer Arm (n=49,51) | -2.6 micrometer | Standard Deviation 9.01 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 24: Left Outer Arm (n=49,52) | -4.5 micrometer | Standard Deviation 9.45 |
| Placebo | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 6: Left Outer Arm (n=58,58) | -0.2 micrometer | Standard Deviation 7.47 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 12: Left Inner Arm (n=54,54) | -0.7 micrometer | Standard Deviation 10.05 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Baseline: Left Cheek (n=58,59) | 10.3 micrometer | Standard Deviation 3.78 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 12: Left Outer Arm (n=54,54) | -2.0 micrometer | Standard Deviation 7.93 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 6: Left Cheek (n=57,59) | -0.7 micrometer | Standard Deviation 5.13 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 18: Left Inner Arm (n=49,50) | -4.6 micrometer | Standard Deviation 13.87 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 12: Left Cheek (n=54,55) | -0.8 micrometer | Standard Deviation 4.34 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 24: Left Outer Arm (n=49,52) | -3.9 micrometer | Standard Deviation 9.69 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 18: Left Cheek (n=49,52) | -3.3 micrometer | Standard Deviation 6.22 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 24: Left Inner Arm (n=49,52) | -4.9 micrometer | Standard Deviation 11.64 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 24: Left Cheek (n=49,53) | -3.3 micrometer | Standard Deviation 5.42 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 18: Left Outer Arm (n=49,51) | -3.6 micrometer | Standard Deviation 10.1 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Baseline: Left Inner Arm (n=58,58) | 29.2 micrometer | Standard Deviation 8.41 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 6: Left Outer Arm (n=58,58) | 0.0 micrometer | Standard Deviation 7.75 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Change at Week 6: Left Inner Arm (n=57,58) | 1.2 micrometer | Standard Deviation 11.61 |
| Imedeen | Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) | Baseline: Left Outer Arm (n=58,58) | 19.4 micrometer | Standard Deviation 6.66 |
Comparison: Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.45895% CI: [-2.21, 1]ANOVA
Comparison: Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.49795% CI: [-2.07, 1.01]ANOVA
Comparison: Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.11395% CI: [-3.05, 0.33]ANOVA
Comparison: Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.70895% CI: [-2.11, 1.44]ANOVA
Comparison: Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.49595% CI: [-2.34, 4.82]ANOVA
Comparison: Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.24395% CI: [-4.96, 1.27]ANOVA
Comparison: Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.45395% CI: [-4.96, 2.23]ANOVA
Comparison: Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.74595% CI: [-2.79, 3.89]ANOVA
Comparison: Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.98795% CI: [-2.44, 2.48]ANOVA
Comparison: Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.21895% CI: [-3.69, 0.85]ANOVA
Comparison: Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.6395% CI: [-3.41, 2.08]ANOVA
Comparison: Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.57695% CI: [-2.06, 3.68]ANOVA
Secondary
Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24
DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).
Time frame: Baseline, Week 6, 12, 18, 24
Population: m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 24: Left Cheek (n=85,91) | 33.1 microsecond | Standard Deviation 53.86 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 18: Left Inner Arm (n=85,91) | 15.3 microsecond | Standard Deviation 45.69 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 6: Left Cheek (n=93,97) | -5.2 microsecond | Standard Deviation 48.13 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 24: Left Inner Arm (n=85,91) | 15.4 microsecond | Standard Deviation 39.36 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Baseline: Left Inner Arm (n=93,97) | 150.0 microsecond | Standard Deviation 41.37 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Baseline: Left Outer Arm (n=93,97) | 120.0 microsecond | Standard Deviation 49.37 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 18: Left Cheek (n=85,91) | 35.1 microsecond | Standard Deviation 47.03 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 6: Left Outer Arm (n=93,97) | -6.4 microsecond | Standard Deviation 42.13 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 6: Left Inner Arm (n=93,97) | -10.6 microsecond | Standard Deviation 48.51 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 12: Left Outer Arm (n=87,92) | -1.5 microsecond | Standard Deviation 45.13 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 12: Left Cheek (n=87,92) | 16.7 microsecond | Standard Deviation 52.7 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 18: Left Outer Arm (n=85,91) | 9.8 microsecond | Standard Deviation 45.27 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 12: Left Inner Arm (n=87,92) | -5.2 microsecond | Standard Deviation 69.84 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 24: Left Outer Arm (n=85,91) | 9.4 microsecond | Standard Deviation 48.6 |
| Placebo | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Baseline: Left Cheek (n=93,97) | 231.7 microsecond | Standard Deviation 54.58 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 24: Left Outer Arm (n=85,91) | 10.2 microsecond | Standard Deviation 50.92 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Baseline: Left Cheek (n=93,97) | 238.7 microsecond | Standard Deviation 69.69 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 6: Left Cheek (n=93,97) | 1.9 microsecond | Standard Deviation 70.39 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 12: Left Cheek (n=87,92) | 20.0 microsecond | Standard Deviation 69.01 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 18: Left Cheek (n=85,91) | 35.5 microsecond | Standard Deviation 70.18 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 24: Left Cheek (n=85,91) | 29.1 microsecond | Standard Deviation 71.44 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Baseline: Left Inner Arm (n=93,97) | 157.2 microsecond | Standard Deviation 52.72 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 6: Left Inner Arm (n=93,97) | -3.7 microsecond | Standard Deviation 54.36 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 12: Left Inner Arm (n=87,92) | 4.4 microsecond | Standard Deviation 61.24 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 18: Left Inner Arm (n=85,91) | 15.7 microsecond | Standard Deviation 55.3 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 24: Left Inner Arm (n=85,91) | 12.0 microsecond | Standard Deviation 53.89 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Baseline: Left Outer Arm (n=93,97) | 130.0 microsecond | Standard Deviation 61.83 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 6: Left Outer Arm (n=93,97) | -3.5 microsecond | Standard Deviation 57.26 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 12: Left Outer Arm (n=87,92) | 1.7 microsecond | Standard Deviation 57.49 |
| Imedeen | Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 | Change at Week 18: Left Outer Arm (n=85,91) | 14.0 microsecond | Standard Deviation 58.47 |
Comparison: Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.58795% CI: [-10.32, 18.18]ANOVA
Comparison: Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.81495% CI: [-14.49, 12.32]ANOVA
Comparison: Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.45395% CI: [-16.14, 8.99]ANOVA
Comparison: Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.19195% CI: [-22.92, 4.61]ANOVA
Comparison: Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.68595% CI: [-10.07, 15.28]ANOVA
Comparison: Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.4895% CI: [-11.67, 23.15]ANOVA
Comparison: Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.29995% CI: [-17.29, 5.34]ANOVA
Comparison: Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.10795% CI: [-20.04, 1.9]ANOVA
Comparison: Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.77695% CI: [-14.39, 10.76]ANOVA
Comparison: Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.60395% CI: [-15.96, 9.29]ANOVA
Comparison: Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.5195% CI: [-15.23, 7.6]ANOVA
Comparison: Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.22595% CI: [-17.7, 4.2]ANOVA
Secondary
Change From Baseline in Skin Thickness at Week 6, 12,18 and 24
Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).
Time frame: Baseline, Week 6, 12, 18, 24
Population: m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time -points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 12: Left Inner Arm (n=87,91) | -11.1 micrometer | Standard Deviation 102.32 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 12: Left Cheek (n=87,92) | 11.3 micrometer | Standard Deviation 167.01 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 24: Left Cheek (n=82,90) | -55.6 micrometer | Standard Deviation 225.02 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 18: Left Cheek (n=84,90) | -21.7 micrometer | Standard Deviation 173.71 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 18: Left Inner Arm (n=84,88) | -16.6 micrometer | Standard Deviation 117.88 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 24: Left Inner Arm (n=82,89) | -73.2 micrometer | Standard Deviation 126.5 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 6: Left Inner Arm (n=91,96) | 4.7 micrometer | Standard Deviation 94.41 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Baseline: Left Outer Arm (n=93,96) | 1349.4 micrometer | Standard Deviation 191.23 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Baseline: Left Cheek (n=93,97) | 1568.2 micrometer | Standard Deviation 234.01 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 6: Left Outer Arm (n=92,96) | 9.1 micrometer | Standard Deviation 106.38 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Baseline: Left Inner Arm (n=93,96) | 1101.8 micrometer | Standard Deviation 159.25 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 12: Left Outer Arm (n=87,91) | 9.5 micrometer | Standard Deviation 101.58 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 6: Left Cheek (n=89,95) | 2.4 micrometer | Standard Deviation 169.5 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 18: Left Outer Arm (n=84,89) | -3.3 micrometer | Standard Deviation 117.71 |
| Placebo | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 24: Left Outer Arm (n=82,89) | -55.3 micrometer | Standard Deviation 144.09 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 18: Left Outer Arm (n=84,89) | -23.1 micrometer | Standard Deviation 120.42 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 18: Left Cheek (n=84,90) | -45.8 micrometer | Standard Deviation 169.6 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 24: Left Cheek (n=82,90) | -81.1 micrometer | Standard Deviation 230.14 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Baseline: Left Inner Arm (n=93,96) | 1076.4 micrometer | Standard Deviation 137.32 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 6: Left Inner Arm (n=91,96) | 3.0 micrometer | Standard Deviation 86.69 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 12: Left Inner Arm (n=87,91) | -15.6 micrometer | Standard Deviation 92.83 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 18: Left Inner Arm (n=84,88) | -43.2 micrometer | Standard Deviation 108.18 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Baseline: Left Cheek (n=93,97) | 1531.1 micrometer | Standard Deviation 243.04 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 6: Left Cheek (n=89,95) | -33.9 micrometer | Standard Deviation 164.03 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 12: Left Cheek (n=87,92) | -37.1 micrometer | Standard Deviation 169.86 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 24: Left Outer Arm (n=82,89) | -55.3 micrometer | Standard Deviation 135.32 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 24: Left Inner Arm (n=82,89) | -66.6 micrometer | Standard Deviation 126.87 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Baseline: Left Outer Arm (n=93,96) | 1332.2 micrometer | Standard Deviation 169.61 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 6: Left Outer Arm (n=92,96) | 17.0 micrometer | Standard Deviation 100.85 |
| Imedeen | Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 | Change at Week 12: Left Outer Arm (n=87,91) | 5.2 micrometer | Standard Deviation 95.81 |
Comparison: Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.26695% CI: [-69.63, 19.31]ANOVA
Comparison: Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.2195% CI: [-73.99, 16.41]ANOVA
Comparison: Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.75395% CI: [-56.55, 40.99]ANOVA
Comparison: Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.63295% CI: [-76.32, 46.51]ANOVA
Comparison: Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.71595% CI: [-19.94, 29.01]ANOVA
Comparison: Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.64895% CI: [-21.04, 33.75]ANOVA
Comparison: Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.31595% CI: [-48.81, 15.83]ANOVA
Comparison: Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.40295% CI: [-19.5, 48.34]ANOVA
Comparison: Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.38195% CI: [-15.49, 40.35]ANOVA
Comparison: Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.91695% CI: [-26.44, 29.43]ANOVA
Comparison: Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.56695% CI: [-43.81, 24.05]ANOVA
Comparison: Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.66795% CI: [-30.78, 47.94]ANOVA
Secondary
Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24
Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm \[millimeter\] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).
Time frame: Baseline, Week 6, 12, 18, 24
Population: m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 12: Left Outer Arm (n=87,92) | -0.1 gram per square meter per hour | Standard Deviation 1.53 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Baseline: Left Cheek (n=93,97) | 11.7 gram per square meter per hour | Standard Deviation 5.27 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 6: Left Cheek (n=93,97) | -0.0 gram per square meter per hour | Standard Deviation 5.21 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 12: Left Cheek (n=87,92) | 0.0 gram per square meter per hour | Standard Deviation 3.72 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 18: Left Cheek (n=85,91) | 0.2 gram per square meter per hour | Standard Deviation 3.84 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 24: Left Cheek (n=85,91) | -0.4 gram per square meter per hour | Standard Deviation 4.15 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Baseline: Left Inner Arm (n=93,97) | 4.8 gram per square meter per hour | Standard Deviation 2 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 6: Left Inner Arm (n=93,97) | -0.3 gram per square meter per hour | Standard Deviation 1.86 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 12: Left Inner Arm (n=87,92) | -0.1 gram per square meter per hour | Standard Deviation 1.79 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 18: Left Inner Arm (n=85,91) | -0.1 gram per square meter per hour | Standard Deviation 1.41 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 24: Left Inner Arm (n=85,91) | -0.4 gram per square meter per hour | Standard Deviation 1.63 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Baseline: Left Outer Arm (n=93,97) | 4.6 gram per square meter per hour | Standard Deviation 1.98 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 6: Left Outer Arm (n=93,97) | -0.2 gram per square meter per hour | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 18: Left Outer Arm (n=85,91) | -0.0 gram per square meter per hour | Standard Deviation 1.39 |
| Placebo | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 24: Left Outer Arm (n=85,91) | -0.4 gram per square meter per hour | Standard Deviation 1.64 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 18: Left Outer Arm (n=85,91) | -0.1 gram per square meter per hour | Standard Deviation 1.72 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 12: Left Inner Arm (n=87,92) | 0.1 gram per square meter per hour | Standard Deviation 1.67 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Baseline: Left Cheek (n=93,97) | 11.0 gram per square meter per hour | Standard Deviation 5.04 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 6: Left Outer Arm (n=93,97) | -0.2 gram per square meter per hour | Standard Deviation 1.81 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 6: Left Cheek (n=93,97) | 0.4 gram per square meter per hour | Standard Deviation 4.34 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 18: Left Inner Arm (n=85,91) | 0.0 gram per square meter per hour | Standard Deviation 1.8 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 12: Left Cheek (n=87,92) | 0.8 gram per square meter per hour | Standard Deviation 4.71 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 12: Left Outer Arm (n=87,92) | -0.2 gram per square meter per hour | Standard Deviation 1.67 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 18: Left Cheek (n=85,91) | 0.8 gram per square meter per hour | Standard Deviation 4.35 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 24: Left Inner Arm (n=85,91) | -0.2 gram per square meter per hour | Standard Deviation 1.72 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 24: Left Cheek (n=85,91) | 0.4 gram per square meter per hour | Standard Deviation 4.29 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 24: Left Outer Arm (n=85,91) | -0.4 gram per square meter per hour | Standard Deviation 1.49 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Baseline: Left Inner Arm (n=93,97) | 4.4 gram per square meter per hour | Standard Deviation 1.9 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Baseline: Left Outer Arm (n=93,97) | 4.1 gram per square meter per hour | Standard Deviation 1.57 |
| Imedeen | Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 | Change at Week 6: Left Inner Arm (n=93,97) | -0.3 gram per square meter per hour | Standard Deviation 2.46 |
Comparison: Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.21495% CI: [-0.46, 2.02]ANOVA
Comparison: Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.02795% CI: [0.12, 2.09]ANOVA
Comparison: Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.04995% CI: [0.01, 1.96]ANOVA
Comparison: Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.01995% CI: [0.2, 2.14]ANOVA
Comparison: Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.44995% CI: [-0.36, 0.8]ANOVA
Comparison: Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.10595% CI: [-0.07, 0.8]ANOVA
Comparison: Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.20595% CI: [-0.14, 0.68]ANOVA
Comparison: Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.195% CI: [-0.06, 0.77]ANOVA
Comparison: Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.24495% CI: [-0.17, 0.66]ANOVA
Comparison: Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.59495% CI: [-0.32, 0.56]ANOVA
Comparison: Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.31795% CI: [-0.2, 0.63]ANOVA
Comparison: Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.p-value: 0.26495% CI: [-0.17, 0.64]ANOVA
Secondary
Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24
Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).
Time frame: Baseline, Week 12, 24
Population: m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24:BOH-Overall (n=92,96) | 0.5 units on scale | Standard Deviation 0.99 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Decolletage-Discoloration (n=93,97) | 5.88 units on scale | Standard Deviation 2.59 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: BOH - Fine L/W (n=92,96) | 0.4 units on scale | Standard Deviation 0.93 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: BOH - Fine L/W (n=92,96) | 0.2 units on scale | Standard Deviation 0.65 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: BOH - Discoloration (n=91,91) | 0.3 units on scale | Standard Deviation 0.94 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Back of Hands-Overall (n=93,97) | 4.89 units on scale | Standard Deviation 2.15 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: BD Overall (n=92,96) | 0.7 units on scale | Standard Deviation 1.13 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Decolletage-Overall (n=93,97) | 5.34 units on scale | Standard Deviation 2.08 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Body - Dryness Overall (n=93,97) | 5.34 units on scale | Standard Deviation 2.23 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Back of Hands - Fine L/W (n=93,97) | 6.23 units on scale | Standard Deviation 2.56 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: Decolletage-W/C (n=92,96) | 0.2 units on scale | Standard Deviation 0.67 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: Decolletage-Overall (n=92,96) | 0.3 units on scale | Standard Deviation 0.7 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: DD (n=87,94) | 0.1 units on scale | Standard Deviation 0.57 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: BOH-Overall (n=92,96) | 0.3 units on scale | Standard Deviation 0.68 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: Decolletage-W/C (n=92,96) | 0.5 units on scale | Standard Deviation 0.94 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Decolletage-W/C (n=93,97) | 5.59 units on scale | Standard Deviation 2.35 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: BOH - Discoloration (n=88,94) | 0.2 units on scale | Standard Deviation 0.69 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: DD (n=88,91) | 0.3 units on scale | Standard Deviation 0.9 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: BD Overall (n=91,96) | 0.6 units on scale | Standard Deviation 0.96 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Back of Hands - Discoloration (n=93,97) | 5.91 units on scale | Standard Deviation 2.62 |
| Placebo | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: Decolletage-Overall (n=92,96) | 0.5 units on scale | Standard Deviation 1 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: BOH - Discoloration (n=91,91) | 0.5 units on scale | Standard Deviation 0.97 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: DD (n=87,94) | 0.3 units on scale | Standard Deviation 0.69 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Back of Hands - Fine L/W (n=93,97) | 6.53 units on scale | Standard Deviation 2.25 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Back of Hands - Discoloration (n=93,97) | 5.83 units on scale | Standard Deviation 2.56 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Decolletage-Overall (n=93,97) | 5.19 units on scale | Standard Deviation 1.92 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Decolletage-W/C (n=93,97) | 5.48 units on scale | Standard Deviation 2.22 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Decolletage-Discoloration (n=93,97) | 6.06 units on scale | Standard Deviation 2.21 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Back of Hands-Overall (n=93,97) | 4.89 units on scale | Standard Deviation 1.98 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: Decolletage-Overall (n=92,96) | 0.7 units on scale | Standard Deviation 1.03 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: Decolletage-W/C (n=92,96) | 0.7 units on scale | Standard Deviation 0.98 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: DD (n=88,91) | 0.6 units on scale | Standard Deviation 1.08 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24:BOH-Overall (n=92,96) | 0.7 units on scale | Standard Deviation 1.08 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: BOH - Fine L/W (n=92,96) | 0.6 units on scale | Standard Deviation 1.02 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Baseline: Body - Dryness Overall (n=93,97) | 5.15 units on scale | Standard Deviation 2.03 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 24: BD Overall (n=92,96) | 0.7 units on scale | Standard Deviation 1.18 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: Decolletage-Overall (n=92,96) | 0.5 units on scale | Standard Deviation 0.75 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: Decolletage-W/C (n=92,96) | 0.4 units on scale | Standard Deviation 0.78 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: BOH-Overall (n=92,96) | 0.4 units on scale | Standard Deviation 0.92 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: BOH - Fine L/W (n=92,96) | 0.4 units on scale | Standard Deviation 0.9 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: BOH - Discoloration (n=88,94) | 0.3 units on scale | Standard Deviation 0.82 |
| Imedeen | Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 | Improvement Week 12: BD Overall (n=91,96) | 0.5 units on scale | Standard Deviation 1.06 |
Comparison: Improvement Week 12, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.01795% CI: [0.23, 0.54]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.07395% CI: [0.09, 0.4]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.11795% CI: [-0.11, 0.22]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.66295% CI: [-0.31, 0.12]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.37395% CI: [-0.05, 0.25]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.29495% CI: [-0.19, 0.12]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.85795% CI: [-0.2, 0.13]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.08895% CI: [0.02, 0.39]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.1195% CI: [-0.02, 0.41]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.11295% CI: [0.07, 0.34]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.61495% CI: [-0.13, 0.13]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.69395% CI: [-0.18, 0.16]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.76295% CI: [-0.06, 0.22]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.66295% CI: [-0.16, 0.13]Cochran-Mantel-Haenszel
Secondary
Participants Improvement Assessment of Face at Week 12 and 24
Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration \[uneven, patchy, blotchy areas of light and dark, age spots, liver spots\], complexion/glow \[bright radiant appearance\] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).
Time frame: Baseline, Week 12, 24
Population: m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: Fine L/W (n=92,96) | 0.6 units on scale | Standard Deviation 1.01 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: Fine L/W (n=93,97) | 6.51 units on scale | Standard Deviation 2.11 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: OA of facial skin (n=93,97) | 5.67 units on scale | Standard Deviation 1.83 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: Under eye dc or bags(n=92,96) | 0.4 units on scale | Standard Deviation 0.88 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: Under eye dc or bags (n=93,97) | 5.80 units on scale | Standard Deviation 2.66 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: Complexion/Glow (n=92,96) | 0.8 units on scale | Standard Deviation 1.16 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: Discoloration (n=93,97) | 5.85 units on scale | Standard Deviation 2.42 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: Complexion/Glow (n=93,97) | 5.19 units on scale | Standard Deviation 2 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: Smoothness (n=92,96) | 0.9 units on scale | Standard Deviation 1.01 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: Smoothness (n=93,97) | 6.69 units on scale | Standard Deviation 1.92 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: Smoothness (n=92,96) | 1.1 units on scale | Standard Deviation 1.22 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: OA of facial skin (n=92,96) | 0.7 units on scale | Standard Deviation 1.06 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: Complexion/Glow (n=92,96) | 0.7 units on scale | Standard Deviation 0.83 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: Fine L/W (n=92,96) | 0.4 units on scale | Standard Deviation 0.84 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: OA of facial skin (n=92,96) | 0.8 units on scale | Standard Deviation 1.23 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: Under eye dc or bags(n=92,96) | 0.3 units on scale | Standard Deviation 0.72 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: Discoloration (n=91,93) | 0.3 units on scale | Standard Deviation 0.97 |
| Placebo | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: Discoloration (n=91,95) | 0.3 units on scale | Standard Deviation 0.8 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: OA of facial skin (n=93,97) | 5.60 units on scale | Standard Deviation 1.62 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: Fine L/W (n=92,96) | 0.8 units on scale | Standard Deviation 1.18 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: Under eye dc or bags(n=92,96) | 0.5 units on scale | Standard Deviation 1.08 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: Discoloration (n=91,95) | 0.4 units on scale | Standard Deviation 1.01 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: Complexion/Glow (n=92,96) | 0.7 units on scale | Standard Deviation 0.86 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: Smoothness (n=92,96) | 1.0 units on scale | Standard Deviation 0.97 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: Discoloration (n=91,93) | 0.5 units on scale | Standard Deviation 1.11 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: Complexion/Glow (n=92,96) | 0.9 units on scale | Standard Deviation 1.12 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: Smoothness (n=92,96) | 1.2 units on scale | Standard Deviation 1.13 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 24: OA of facial skin (n=92,96) | 1.0 units on scale | Standard Deviation 1.26 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: Discoloration (n=93,97) | 6.59 units on scale | Standard Deviation 2.23 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: Fine L/W (n=93,97) | 6.46 units on scale | Standard Deviation 1.89 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: Under eye dc or bags (n=93,97) | 5.82 units on scale | Standard Deviation 2.64 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: Complexion/Glow (n=93,97) | 5.02 units on scale | Standard Deviation 1.75 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Baseline: Smoothness (n=93,97) | 6.49 units on scale | Standard Deviation 1.86 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: OA of facial skin (n=92,96) | 0.8 units on scale | Standard Deviation 0.92 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: Fine L/W (n=92,96) | 0.6 units on scale | Standard Deviation 0.89 |
| Imedeen | Participants Improvement Assessment of Face at Week 12 and 24 | Improvement Week 12: Under eye dc or bags(n=92,96) | 0.3 units on scale | Standard Deviation 0.95 |
Comparison: Improvement Week 12, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.68895% CI: [-0.1, 0.27]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.44595% CI: [-0.08, 0.33]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.31895% CI: [0.01, 0.4]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.63395% CI: [-0.15, 0.12]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.99695% CI: [-0.23, 0.19]Cochran-Mantel-Haenszel
Comparison: Improvement Week 12, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.43295% CI: [-0.13, 0.25]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.83395% CI: [-0.13, 0.19]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.17195% CI: [0.06, 0.39]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.79695% CI: [-0.16, 0.12]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.94295% CI: [-0.23, 0.16]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.40595% CI: [-0.05, 0.28]Cochran-Mantel-Haenszel
Comparison: Improvement Week 24, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.p-value: 0.68795% CI: [-0.14, 0.26]Cochran-Mantel-Haenszel
Secondary
Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24
IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).
Time frame: Week 24
Population: m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24 | -0.2 units on scale | Standard Deviation 0.86 |
| Imedeen | Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24 | -0.1 units on scale | Standard Deviation 0.82 |
Comparison: Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for Glogau classification of photoaging and site.p-value: 0.56895% CI: [-0.19, 0.27]Cochran-Mantel-Haenszel