Trial Outcomes & Findings for 8-Week Atopic Dermatitis (AD) Treatment Study (NCT NCT03386032)
NCT ID: NCT03386032
Last Updated: 2020-12-17
Results Overview
SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments \[Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103 SCORAD is calculated: Extent 7\*Intensity SCORAD = --------- + ---------------- + Subjective 5 2
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
65 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2020-12-17
Participant Flow
Participant milestones
| Measure |
Investigational OTC Cream
Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
Investigational OTC Cream: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
|
Placebo Cream
Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
0.05% Desonide Cream
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
0.05% Desonide: Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
18
|
11
|
|
Overall Study
COMPLETED
|
18
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
18
|
7
|
0
|
Reasons for withdrawal
| Measure |
Investigational OTC Cream
Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
Investigational OTC Cream: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
|
Placebo Cream
Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
0.05% Desonide Cream
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
0.05% Desonide: Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
2
|
0
|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
0
|
Baseline Characteristics
8-Week Atopic Dermatitis (AD) Treatment Study
Baseline characteristics by cohort
| Measure |
Investigational OTC Cream
n=36 Participants
Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
Investigational OTC Cream: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
|
Placebo Cream
n=18 Participants
Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
0.05% Desonide Cream
n=11 Participants
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
0.05% Desonide: Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
42 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 14.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
18 participants
n=7 Participants
|
11 participants
n=5 Participants
|
65 participants
n=4 Participants
|
|
SCORAD
|
49.18 units on a scale
STANDARD_DEVIATION 2.39 • n=5 Participants
|
52.21 units on a scale
STANDARD_DEVIATION 3.36 • n=7 Participants
|
45.22 units on a scale
STANDARD_DEVIATION 4.33 • n=5 Participants
|
49.3 units on a scale
STANDARD_DEVIATION 14.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: Subjects with moderate Atopic Dermatitis as defined by Baseline SCORAD 25-40
SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments \[Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103 SCORAD is calculated: Extent 7\*Intensity SCORAD = --------- + ---------------- + Subjective 5 2
Outcome measures
| Measure |
Investigational OTC Cream
n=11 Participants
Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
Investigational OTC Cream: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
|
Placebo Cream
n=4 Participants
Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
0.05% Desonide Cream
n=3 Participants
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
0.05% Desonide: Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
|---|---|---|---|
|
Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis
|
-12.2 units on a scale
Standard Error 3.99
|
9.3 units on a scale
Standard Error 6.51
|
-17.5 units on a scale
Standard Error 8.29
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: Subjects with severe Atopic Dermatitis (Baseline SCORAD = 41+)
SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments \[Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103 SCORAD is calculated: Extent 7\*Intensity SCORAD = --------- + ---------------- + Subjective 5 2
Outcome measures
| Measure |
Investigational OTC Cream
n=19 Participants
Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
Investigational OTC Cream: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
|
Placebo Cream
n=11 Participants
Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
0.05% Desonide Cream
n=7 Participants
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
0.05% Desonide: Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
|---|---|---|---|
|
Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis
|
-6.0 units on a scale
Standard Error 2.8
|
-20.3 units on a scale
Standard Error 3.7
|
-18.0 units on a scale
Standard Error 4.5
|
Adverse Events
Investigational OTC Cream
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Cream
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.05% Desonide Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Investigational OTC Cream
n=36 participants at risk
Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
Investigational OTC Cream: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
|
Placebo Cream
n=18 participants at risk
Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
0.05% Desonide Cream
n=11 participants at risk
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
0.05% Desonide: Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
Placebo Cream: Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Atopic /Other
|
5.6%
2/36 • Number of events 2 • Adverse event data were collected during the subject's participation in the study (up to 8 weeks).
|
11.1%
2/18 • Number of events 2 • Adverse event data were collected during the subject's participation in the study (up to 8 weeks).
|
0.00%
0/11 • Adverse event data were collected during the subject's participation in the study (up to 8 weeks).
|
Additional Information
Laurie Moulton, M.S., Statistical Group Scientist
The Procter & Gamble Company
Phone: +1-513-544-3636
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is employed by a contract research organization that is solely responsible for execution of the protocol. The contract research organization (and the PI) have signed a non-disclosure agreement, agreeing to keep all study-related information confidential. The Sponsor is responsible for data analysis.
- Publication restrictions are in place
Restriction type: OTHER