Skin Care
Conditions
Brief summary
This study will assess the cosmetic changes of a cosmetic topical retinoid product in participants with moderate to severe photodamage utilizing non-invasive in vivo skin imaging instrumentation.
Interventions
OTHERRetinol Complex 0.5
Retinol Complex 0.5 topically in the evening.
OTHERFacial cleanser
Facial cleanser in the morning and in the evening.
OTHERMoisturizing lotion
Fragrance free moisturizing lotion in the morning and in the evening.
OTHERSunscreen
Sunscreen broad spectrum sun protection factor (SPF) 35 topically in the morning and as needed.
DEVICESkin Imaging
Non-invasive in vivo skin imaging will be taken with the VivoSight Dx Optical Coherence Tomography (OCT) and VivaScope 1500
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants with Fitzpatrick skin type I-IV * Presence of moderate to severe facial photodamage * Participants taking hormone replacement or hormones for birth control, willing to stop or change this medication for the duration of the study * Willingness to cleanse the face and remove all makeup at least 15 minutes prior to each scheduled clinic visit * Willingness to not use any other products, including self-tanners on their facial skin during the study * Willingness to avoid as much as possible, direct and prolonged sun exposure for the duration of the study (including tanning beds), especially from 10 AM to 2 PM. Participants are asked to wear protective clothing prior to and during exposure.
Exclusion criteria
* Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, excessive scarring, tattoos, or other skin conditions in the test areas that would interfere with the assessments of this study * Individuals who are nursing, pregnant, or planning to become pregnant during the study * Individuals with uncontrolled disease such as diabetes, hypertension, hyper or hypothyroidism, active hepatitis, immune deficiency, or autoimmune * Individuals who have a pre-existing or dormant dermatologic condition (e.g., psoriasis, atopic dermatitis, rosacea, skin cancer, etc.) * Individuals who require electrolysis, waxing, or use depilatories on the face during the study * Chemical peel or microdermabrasion within 4 weeks of study start * Retin-A®, Retin-A Micro®, Renova®, Avita®,Tazorac®, Avage® or Differin® or other similar prescription drugs within 3 months of study start * Cosmetic injections (filler and/or toxins, i.e. Juvederm, Radiesse, Botox, etc.), non-ablative laser or fractional laser resurfacing * Accutane® or other oral retinoid, Ablative procedures (i.e. laser, chemical, cosmetic surgeries) within 12 months of study start * Participants who have planned surgeries or procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Overall Photodamage Score | Baseline (Day 1) to Week 12 | The investigator assessed the participant's overall photodamage using a 10-point scale where None (0)= Facial skin is smooth to the touch, without significant fine/coarse line or skin tone unevenness in any areas (periocular, cheeks, forehead and perioral areas) to Severe (7 to 9)= Facial skin shows 3 or more areas (periocular, cheeks, forehead and perioral areas) of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. |
| Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Baseline (Day 1) to Week 12 | The investigator assessed the participant's appearance of fine lines/wrinkles using a 10-point scale where None (0)= No fine lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. |
| Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Baseline (Day 1) to Week 12 | The investigator assessed the participant's appearance of coarse lines/wrinkles using a 10-point scale where None (0)= No coarse lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. |
| Change From Baseline in Tactile Roughness Score | Baseline (Day 1) to Week 12 | The investigator assessed the participant's tactile roughness in the entire face using a 10-point scale where None (0)= No roughness of the treatment area; skin is completely smooth and pliable to Severe (7 to 9)= Marked roughness of the treatment area associated with stiff feeling at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | Baseline (Day 1) to Week 12 | The investigator assessed the global improvement in the participant's overall appearance of coarse lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of coarse lines/wrinkles (approximately 95% or better overall improvement). |
| Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale | Baseline (Day 1) to Week 12 | The investigator assessed the participant's skin roughness using the Allergan Skin Roughness Visual 5-Point Scale where None (0)= Smooth visual skin texture to Extreme (4)= Extremely coarse visual skin texture, crosshatched deep creases; extreme elastosis at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. |
| Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness) | Baseline (Day 1) to Week 12 | Triplicate spectrophotometer readings were taken of the participant's face (Normal Skin and Target Lesions) at Baseline and Week 12. L\* value scores range from 0=black to 100=white. An increase in the spectrophotometer L\* values indicates improvement. A positive change from Baseline indicates improvement. |
| Investigator's Global Improvement Assessment for Tactile Roughness | Baseline (Day 1) to Week 12 | The investigator assessed the global improvement in the participant's overall tactile roughness compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of tactile roughness (approximately 95% or better overall improvement). |
| Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale | Baseline (Day 1) to Week 12 | The investigator assessed the participant's fine lines using the Allergan Fine Lines Visual 5-Point Scale where None (0)= No fine lines to Diffuse (4)= Diffuse superficial lines; crosshatching at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement. |
| Investigator's Global Improvement Assessment for Overall Photodamage | Baseline (Day 1) to Week 12 | The investigator assessed the global improvement in the participant's overall photodamage compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Almost complete improvement of the condition with a trace of signs/symptoms remaining (approximately 95% or better overall improvement). |
| Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | Baseline (Day 1) to Week 12 | The investigator assessed the global improvement in the participant's overall appearance of fine lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of fine lines/wrinkles (approximately 95% or better overall improvement). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Retinol Complex 0.5 During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrew Consent | 3 |
Baseline characteristics
| Characteristic | Retinol Complex 0.5 |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 7.9 |
| Race/Ethnicity, Customized Asian | 8 Participants |
| Race/Ethnicity, Customized Caucasian | 11 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 12 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
The investigator assessed the participant's appearance of coarse lines/wrinkles using a 10-point scale where None (0)= No coarse lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retinol Complex 0.5 | Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Baseline (Forehead) | 4.9 score on a scale | Standard Deviation 1.4 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Change from Baseline at Week 12 (Cheeks) | -1.1 score on a scale | Standard Deviation 1.1 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Change from BL at Week 12 (Forehead) | -0.6 score on a scale | Standard Deviation 1.1 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Baseline (Periocular) | 6.0 score on a scale | Standard Deviation 1.2 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Change from Baseline at Week 12 (Periocular) | -0.7 score on a scale | Standard Deviation 1 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Baseline (Cheeks) | 3.5 score on a scale | Standard Deviation 2.4 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Baseline (Perioral) | 4.4 score on a scale | Standard Deviation 1.9 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Change from BL at Week 12 (Perioral) | -0.2 score on a scale | Standard Deviation 1.2 |
Comparison: Change from Baseline at Week 12 (Forehead)p-value: 0.02Paired t-test
Comparison: Change from Baseline at Week 12 (Periocular)p-value: 0.006Paired t-test
Comparison: Change from Baseline at Week 12 (Cheeks)p-value: <0.001Paired t-test
Comparison: Change from Baseline at Week 12 (Perioral)p-value: 0.5Paired t-test
Primary
Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
The investigator assessed the participant's appearance of fine lines/wrinkles using a 10-point scale where None (0)= No fine lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retinol Complex 0.5 | Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Change from BL at Week 12 (Periocular) | -1.0 score on a scale | Standard Deviation 1.8 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Baseline (Cheeks) | 3.6 score on a scale | Standard Deviation 1.5 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Change from BL at Week 12 (Perioral) | -0.9 score on a scale | Standard Deviation 1.2 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Baseline (Forehead) | 3.4 score on a scale | Standard Deviation 1.5 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Change from BL at Week 12 (Forehead) | -0.8 score on a scale | Standard Deviation 1.2 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Baseline (Periocular) | 4.7 score on a scale | Standard Deviation 1.5 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Change from BL at Week 12 (Cheeks) | -1.1 score on a scale | Standard Deviation 1.3 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed) | Baseline (Perioral) | 4.0 score on a scale | Standard Deviation 1.6 |
Comparison: Change from Baseline at Week 12 (Forehead)p-value: 0.005Paired t-test
Comparison: Change from Baseline at Week 12 (Periocular)p-value: 0.02Paired t-test
Comparison: Change from Baseline at Week 12 (Cheeks)p-value: 0.0006Paired t-test
Comparison: Change from Baseline at Week 12 (Perioral)p-value: 0.001Paired t-test
Primary
Change From Baseline in Overall Photodamage Score
The investigator assessed the participant's overall photodamage using a 10-point scale where None (0)= Facial skin is smooth to the touch, without significant fine/coarse line or skin tone unevenness in any areas (periocular, cheeks, forehead and perioral areas) to Severe (7 to 9)= Facial skin shows 3 or more areas (periocular, cheeks, forehead and perioral areas) of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retinol Complex 0.5 | Change From Baseline in Overall Photodamage Score | Baseline (BL) | 5.6 score on a scale | Standard Deviation 0.9 |
| Retinol Complex 0.5 | Change From Baseline in Overall Photodamage Score | Change from BL at Week 12 | -0.8 score on a scale | Standard Deviation 0.5 |
Comparison: Change from Baseline at Week 12p-value: <0.001Paired t-test
Primary
Change From Baseline in Tactile Roughness Score
The investigator assessed the participant's tactile roughness in the entire face using a 10-point scale where None (0)= No roughness of the treatment area; skin is completely smooth and pliable to Severe (7 to 9)= Marked roughness of the treatment area associated with stiff feeling at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retinol Complex 0.5 | Change From Baseline in Tactile Roughness Score | Baseline | 4.0 score on a scale | Standard Deviation 1.7 |
| Retinol Complex 0.5 | Change From Baseline in Tactile Roughness Score | Change from BL at Week 12 | -1.1 score on a scale | Standard Deviation 1.6 |
Comparison: Change from Baseline at Week 12p-value: 0.002Paired t-test
Secondary
Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale
The investigator assessed the participant's fine lines using the Allergan Fine Lines Visual 5-Point Scale where None (0)= No fine lines to Diffuse (4)= Diffuse superficial lines; crosshatching at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retinol Complex 0.5 | Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale | Baseline | 4.0 score on a scale | Standard Deviation 1.7 |
| Retinol Complex 0.5 | Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale | Change from BL at Week 12 | -0.3 score on a scale | Standard Deviation 0.6 |
Comparison: Change from Baseline at Week 12p-value: 0.02Paired t-test
Secondary
Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale
The investigator assessed the participant's skin roughness using the Allergan Skin Roughness Visual 5-Point Scale where None (0)= Smooth visual skin texture to Extreme (4)= Extremely coarse visual skin texture, crosshatched deep creases; extreme elastosis at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participant who applied study treatment and completed one follow-up visit after test product was initiated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retinol Complex 0.5 | Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale | Baseline | 1.8 score on a scale | Standard Deviation 1.1 |
| Retinol Complex 0.5 | Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale | Change from BL at Week 12 | -0.5 score on a scale | Standard Deviation 0.6 |
Comparison: Change from Baseline at Week 12p-value: 0.0008Paired t-test
Secondary
Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)
Triplicate spectrophotometer readings were taken of the participant's face (Normal Skin and Target Lesions) at Baseline and Week 12. L\* value scores range from 0=black to 100=white. An increase in the spectrophotometer L\* values indicates improvement. A positive change from Baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. Number analyzed is the number of participants with data available at the given time-point for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retinol Complex 0.5 | Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness) | Baseline (Normal Skin) | 62.0 score on a scale | Standard Error 3.7 |
| Retinol Complex 0.5 | Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness) | Change from BL at Week 12 (Normal Skin) | 0.3 score on a scale | Standard Error 1.8 |
| Retinol Complex 0.5 | Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness) | Baseline (Target Lesion) | 57.8 score on a scale | Standard Error 5.7 |
| Retinol Complex 0.5 | Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness) | Change from BL at Week 12 (Target Lesion) | 0.3 score on a scale | Standard Error 1.7 |
Comparison: Change from Baseline at Week 12 (Normal Skin)p-value: 0.3Paired t-test
Comparison: Change from Baseline at Week 12 (Target Lesion)p-value: 0.4Paired t-test
Secondary
Investigator's Global Improvement Assessment for Overall Photodamage
The investigator assessed the global improvement in the participant's overall photodamage compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Almost complete improvement of the condition with a trace of signs/symptoms remaining (approximately 95% or better overall improvement).
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retinol Complex 0.5 | Investigator's Global Improvement Assessment for Overall Photodamage | 1.5 score on a scale | Standard Deviation 0.7 |
Secondary
Investigator's Global Improvement Assessment for Tactile Roughness
The investigator assessed the global improvement in the participant's overall tactile roughness compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of tactile roughness (approximately 95% or better overall improvement).
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retinol Complex 0.5 | Investigator's Global Improvement Assessment for Tactile Roughness | 1.3 score on a scale | Standard Deviation 1.1 |
Secondary
Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
The investigator assessed the global improvement in the participant's overall appearance of coarse lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of coarse lines/wrinkles (approximately 95% or better overall improvement).
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retinol Complex 0.5 | Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | Week 12 (Forehead) | 0.8 score on a scale | Standard Deviation 0.8 |
| Retinol Complex 0.5 | Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | Week 12 (Periocular) | 1.6 score on a scale | Standard Deviation 0.8 |
| Retinol Complex 0.5 | Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | Week 12 (Cheeks) | 0.9 score on a scale | Standard Deviation 0.8 |
| Retinol Complex 0.5 | Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | Week 12 (Perioral) | 0.8 score on a scale | Standard Deviation 0.8 |
Secondary
Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
The investigator assessed the global improvement in the participant's overall appearance of fine lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of fine lines/wrinkles (approximately 95% or better overall improvement).
Time frame: Baseline (Day 1) to Week 12
Population: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retinol Complex 0.5 | Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | Week 12 (Periocular) | 1.6 score on a scale | Standard Deviation 0.9 |
| Retinol Complex 0.5 | Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | Week 12 (Cheeks) | 1.3 score on a scale | Standard Deviation 0.6 |
| Retinol Complex 0.5 | Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | Week 12 (Perioral) | 1.2 score on a scale | Standard Deviation 0.7 |
| Retinol Complex 0.5 | Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed) | Week 12 (Forehead) | 1.1 score on a scale | Standard Deviation 0.6 |