Atopic Dermatitis
Conditions
Brief summary
Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to its vehicle.
Detailed description
Study application was performed once daily, 7 days a week for 6 weeks.
Interventions
DRUGCD5024 0.3% cream
Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeter square (mg/cm\^2) once daily for 6 weeks.
DRUGPlacebo
Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. The participant was a male or female aged 18 to 60 years old inclusive at Screening. 2. The participant presented with a total body surface area (tBSA) less than or equal to (\>=) 2 square meter (m\^2) at Screening. 3. The participant had atopic dermatitis for at least 6 months prior to Day 1. The clinical diagnosis of atopic dermatitis must be confirmed with the criteria of Hanifin and Rajka at the screening visit. 4. Atopic dermatitis must be stable for at least one month before the screening visit (according to participant). 5. The participant had a Body Surface Area (BSA) affected by AD ranging from 1% inclusive to 10% inclusive at Day 1, excluding scalp and genitals. 6. The participant had an overall Investigator's Global Assessment (IGA) score of 3 (moderate) at Day 1;
Exclusion criteria
1. The participant was a pregnant female, is breastfeeding or intends to conceive a child during the study, 2. The participant had any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results (e.g. extensive scaring or pigmented lesion in a treated area), and/or put the participant at significant risk according to Investigator's judgment if he/she participates in the clinical trial (e.g. active cancer, AIDS, insulin-dependent diabetes…) at Screening or Day 1. 3. The participant presented with an acute flare of AD at Day 1. 4. The participant had active cutaneous bacterial or viral infection in any treated area at baseline (e.g. clinically infected AD) at Screening or Day 1. 5. The participant had a history of confounding skin condition (e.g. psoriasis, erythroderma) or a history of Netherton syndrome at Screening. 6. The participant had a past history of serious persistent neurological disorders such as seizures, multiple sclerosis, or neurological signs or symptoms at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43 | Baseline, Day 43 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Days 8, 15, 22, 29, 36 and 43 | IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). Success rate was defined as percentage of participants who achieved an IGA score of 1 (almost clear) or 0 (Clear) at specified visits. All missing values were imputed by LOCF. |
| Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Baseline, Days 8, 15, 22, 29, 36 and 43 | The TSS was the sum of individual clinical severity scores for 5 signs of AD (erythema, induration/papulation, oozing/crusting, excoriation and lichenification). The severity of each sign was evaluated by using a 4-graded scale (0: none; 1: mild; 2: moderate; 3: severe). The total score ranges from 0 to 15, where higher score indicated worse severity of AD. All missing values were imputed by LOCF. |
| Percent Change From Baseline in EASI at Each Visit | Baseline, Days 8,15, 22, 29, 36 and 43 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. All missing values were imputed by LOCF. |
| Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Baseline, Weeks 1, 2, 3, 4, 5 and 6 | Pruritus NRS was a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 = 'no itch' and 10 = 'worst itch imaginable', where higher score indicated very severe itch. All missing values were imputed by LOCF. |
| Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43 | Baseline, Day 43 | Participants were asked for a response that best described their pruritus intensity in last 24 hours, to rate their itch using a list of adjectives describing different levels of symptom intensity rated on a scale of 0 to 3 that is (i.e.) 0 = No itch, 1 = low, 2 = Moderate and 3 = Severe, where higher score indicated very severe itch. All missing values were imputed by LOCF. |
| Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Baseline, Days 8, 15, 22, 29, 36 and 43 | SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. Higher scores indicated worse outcome. All missing values were imputed by LOCF. |
Countries
Canada
Participant flow
Recruitment details
The study was conducted at 5 centers in Canada between 01 November 2016 and 26 June 2017.
Pre-assignment details
A total of 101 participants were screened in the study. Out of which, 63 participants were randomized in a ratio of 1:1 to receive CD5024 0.3 percent (%) cream or its vehicle. Screen failures were mainly due to exclusion criteria met.
Participants by arm
| Arm | Count |
|---|---|
| CD5024 0.3% Cream Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks. | 32 |
| Placebo Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks. | 31 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 4 |
| Overall Study | Other | 1 | 2 |
Baseline characteristics
| Characteristic | CD5024 0.3% Cream | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 27.2 years STANDARD_DEVIATION 9.19 | 30.0 years STANDARD_DEVIATION 10.77 | 28.6 years STANDARD_DEVIATION 9.98 |
| Eczema Area and Severity Index (EASI) Score | 5.341 score on a scale STANDARD_DEVIATION 2.432 | 5.371 score on a scale STANDARD_DEVIATION 2.652 | 5.356 score on a scale STANDARD_DEVIATION 2.542 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 25 Participants | 23 Participants | 48 Participants |
| Sex: Female, Male Female | 21 Participants | 26 Participants | 47 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 31 |
| other Total, other adverse events | 16 / 32 | 21 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 |
Outcome results
Primary
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF).
Time frame: Baseline, Day 43
Population: The Intent-to-treat (ITT) efficacy analysis set was defined as any participant who were randomized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CD5024 0.3% Cream | Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43 | -2.64 score on a scale | Standard Error 0.41 |
| Placebo | Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43 | -2.36 score on a scale | Standard Error 0.44 |
p-value: 0.63295% CI: [-1.46, 0.89]ANCOVA
Secondary
Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit
Pruritus NRS was a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 = 'no itch' and 10 = 'worst itch imaginable', where higher score indicated very severe itch. All missing values were imputed by LOCF.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5 and 6
Population: The ITT efficacy analysis set was defined as any participant who were randomized. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD5024 0.3% Cream | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 1 | -0.2 score on a scale | Standard Deviation 1.1 |
| CD5024 0.3% Cream | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 2 | -0.6 score on a scale | Standard Deviation 1.9 |
| CD5024 0.3% Cream | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 3 | -0.7 score on a scale | Standard Deviation 2.1 |
| CD5024 0.3% Cream | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 4 | -1.0 score on a scale | Standard Deviation 2.3 |
| CD5024 0.3% Cream | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 5 | -1.0 score on a scale | Standard Deviation 2.2 |
| CD5024 0.3% Cream | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 6 | -1.3 score on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 5 | -0.5 score on a scale | Standard Deviation 2 |
| Placebo | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 1 | -0.2 score on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 4 | -0.3 score on a scale | Standard Deviation 2.1 |
| Placebo | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 2 | -0.3 score on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 6 | -0.6 score on a scale | Standard Deviation 2.1 |
| Placebo | Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit | Week 3 | -0.4 score on a scale | Standard Deviation 1.9 |
Secondary
Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43
Participants were asked for a response that best described their pruritus intensity in last 24 hours, to rate their itch using a list of adjectives describing different levels of symptom intensity rated on a scale of 0 to 3 that is (i.e.) 0 = No itch, 1 = low, 2 = Moderate and 3 = Severe, where higher score indicated very severe itch. All missing values were imputed by LOCF.
Time frame: Baseline, Day 43
Population: The ITT efficacy analysis set was defined as any participant who were randomized. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD5024 0.3% Cream | Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43 | -.31 score on a scale | Standard Deviation 0.79 |
| Placebo | Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43 | -.13 score on a scale | Standard Deviation 0.74 |
Secondary
Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). Success rate was defined as percentage of participants who achieved an IGA score of 1 (almost clear) or 0 (Clear) at specified visits. All missing values were imputed by LOCF.
Time frame: Days 8, 15, 22, 29, 36 and 43
Population: The ITT efficacy analysis set was defined as any participant who were randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD5024 0.3% Cream | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 8 | 0 percentage of participants |
| CD5024 0.3% Cream | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 15 | 3.13 percentage of participants |
| CD5024 0.3% Cream | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 22 | 9.38 percentage of participants |
| CD5024 0.3% Cream | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 29 | 15.6 percentage of participants |
| CD5024 0.3% Cream | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 36 | 21.9 percentage of participants |
| CD5024 0.3% Cream | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 43 | 37.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 36 | 16.1 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 8 | 3.23 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 29 | 6.45 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 15 | 6.45 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 43 | 9.68 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) | Day 22 | 9.68 percentage of participants |
Secondary
Percent Change From Baseline in EASI at Each Visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. All missing values were imputed by LOCF.
Time frame: Baseline, Days 8,15, 22, 29, 36 and 43
Population: The ITT efficacy analysis set was defined as any participant who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD5024 0.3% Cream | Percent Change From Baseline in EASI at Each Visit | Day 8 | -8.7 percent change | Standard Deviation 19.1 |
| CD5024 0.3% Cream | Percent Change From Baseline in EASI at Each Visit | Day 15 | -21.0 percent change | Standard Deviation 37.5 |
| CD5024 0.3% Cream | Percent Change From Baseline in EASI at Each Visit | Day 22 | -29.1 percent change | Standard Deviation 40.7 |
| CD5024 0.3% Cream | Percent Change From Baseline in EASI at Each Visit | Day 29 | -34.5 percent change | Standard Deviation 59.9 |
| CD5024 0.3% Cream | Percent Change From Baseline in EASI at Each Visit | Day 36 | -43.1 percent change | Standard Deviation 35.3 |
| CD5024 0.3% Cream | Percent Change From Baseline in EASI at Each Visit | Day 43 | -46.4 percent change | Standard Deviation 38.8 |
| Placebo | Percent Change From Baseline in EASI at Each Visit | Day 36 | -28.8 percent change | Standard Deviation 44.7 |
| Placebo | Percent Change From Baseline in EASI at Each Visit | Day 8 | -5.5 percent change | Standard Deviation 39.6 |
| Placebo | Percent Change From Baseline in EASI at Each Visit | Day 29 | -21.0 percent change | Standard Deviation 41.7 |
| Placebo | Percent Change From Baseline in EASI at Each Visit | Day 15 | -10.7 percent change | Standard Deviation 43.7 |
| Placebo | Percent Change From Baseline in EASI at Each Visit | Day 43 | -24.6 percent change | Standard Deviation 62.7 |
| Placebo | Percent Change From Baseline in EASI at Each Visit | Day 22 | -26.7 percent change | Standard Deviation 35.8 |
Secondary
Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit
SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. Higher scores indicated worse outcome. All missing values were imputed by LOCF.
Time frame: Baseline, Days 8, 15, 22, 29, 36 and 43
Population: The ITT efficacy analysis set was defined as any participant who were randomized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CD5024 0.3% Cream | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 8 | -16.28 percent change | Standard Error 4.29 |
| CD5024 0.3% Cream | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 15 | -30.76 percent change | Standard Error 5.51 |
| CD5024 0.3% Cream | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 22 | -32.02 percent change | Standard Error 5.84 |
| CD5024 0.3% Cream | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 29 | -39.14 percent change | Standard Error 6.51 |
| CD5024 0.3% Cream | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 36 | -46.38 percent change | Standard Error 6.67 |
| CD5024 0.3% Cream | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 43 | -48.92 percent change | Standard Error 7.26 |
| Placebo | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 36 | -40.10 percent change | Standard Error 7.03 |
| Placebo | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 8 | -16.00 percent change | Standard Error 4.52 |
| Placebo | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 29 | -31.81 percent change | Standard Error 6.86 |
| Placebo | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 15 | -20.49 percent change | Standard Error 5.81 |
| Placebo | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 43 | -41.48 percent change | Standard Error 7.65 |
| Placebo | Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit | Day 22 | -30.73 percent change | Standard Error 6.16 |
Secondary
Percent Change From Baseline in Total Sum Score (TSS) at Each Visit
The TSS was the sum of individual clinical severity scores for 5 signs of AD (erythema, induration/papulation, oozing/crusting, excoriation and lichenification). The severity of each sign was evaluated by using a 4-graded scale (0: none; 1: mild; 2: moderate; 3: severe). The total score ranges from 0 to 15, where higher score indicated worse severity of AD. All missing values were imputed by LOCF.
Time frame: Baseline, Days 8, 15, 22, 29, 36 and 43
Population: The ITT efficacy analysis set was defined as any participant who were randomized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CD5024 0.3% Cream | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 8 | -15.35 percent change | Standard Error 4.51 |
| CD5024 0.3% Cream | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 15 | -27.94 percent change | Standard Error 5.76 |
| CD5024 0.3% Cream | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 22 | -29.38 percent change | Standard Error 6.23 |
| CD5024 0.3% Cream | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 29 | -37.23 percent change | Standard Error 6.64 |
| CD5024 0.3% Cream | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 36 | -45.01 percent change | Standard Error 6.75 |
| CD5024 0.3% Cream | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 43 | -47.63 percent change | Standard Error 7.3 |
| Placebo | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 36 | 42.24 percent change | Standard Error 7.11 |
| Placebo | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 8 | -17.30 percent change | Standard Error 4.75 |
| Placebo | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 29 | -34.44 percent change | Standard Error 6.99 |
| Placebo | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 15 | -20.82 percent change | Standard Error 6.07 |
| Placebo | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 43 | -45.00 percent change | Standard Error 7.69 |
| Placebo | Percent Change From Baseline in Total Sum Score (TSS) at Each Visit | Day 22 | -33.57 percent change | Standard Error 6.57 |