Atopic Dermatitis Eczema
Conditions
Brief summary
This is a study to investigate the clinical effectiveness of the Sponsor's experimental cream treatment on eczema as measured by visual grading of SCORAD (scoring of atopic dermatitis).
Detailed description
This will be a 9-week, randomized, double blind, parallel comparison study consisting of a 1-week washout phase followed by an 8-week treatment phase. This study will be executed by one clinical research company utilizing two test sites and up to 62 subjects with moderate or severe atopic dermatitis, ages 12-65, will be enrolled. Subjects that are enrolled will be placed on one of three products (e.g. Sponsor's Experimental Cream Treatment, a basic moisturizer, or a positive control - Desonide) and will be required to use the assigned product twice a day for the duration of the 8-week treatment phase.
Interventions
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.
DRUG0.05% 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.
OTHERPlacebo 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.
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
As above
Intervention model description
Subjects will be randomized and balanced into one of the 3 treatment groups by their baseline SCORAD grade (moderate = 25-40 and severe = 41+) and ethnicity (black or non-black).
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Is a generally healthy, male or female, 12-65 years old, inclusive; * Diagnosis of moderate or greater Atopic Dermatitis as determined by SCORAD (SCORAD \>=25); * Is able to read and understand instructions in English.
Exclusion criteria
* Is currently participating or has participated in another interventional clinical study in the past 2 weeks; * Currently or has been diagnosed or treated for cancer in the past 5 years; * Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies); * Has used systemic treatments that could affect AD within 30 days or 5 half- lives. (i.e. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids); * Has a known hypersensitivity to any corticosteroid creams; * Has been diagnosed with any allergies to Oat or derivatives; * Has any active infections or has used antibiotics in the past 7 days; * Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne); * Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results; * Has used any immunosuppressant drugs or immunotherapy within the past 30days or 5 half-lives; * Is an employee of the sponsor company or clinical testing site; * Is diabetic; * Presents with the presence of an active or chronic allergic reaction as evidenced by an irregular white cell count determined by eosinophils \> 0.3 X 109/L at Screening Visit; * Is planning a trip to a sunny climate, to use tanning booths or use other UV sources throughout the course of this study; * Has a history of hypersensitivity to any substance in investigational preparation or to Desonide; * Has any clinically significant medical condition or laboratory abnormality that would, in the opinion of the Investigator, put the patient at undue risk or interfere with the interpretation of the study results; * Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study; * Is currently pregnant or lactating or planning to become pregnant in the next 6 months; * Has other skin conditions that might interfere with AD diagnosis and/or evaluation (i.e. psoriasis current active viral, bacterial and fungal skin infections) as assessed by the Investigator; * Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis | Baseline to Week 8 | 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 |
| Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis | Baseline to Week 8 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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. | 18 |
| 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. | 11 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 0 |
| Overall Study | Lack of Efficacy | 6 | 2 | 0 |
| Overall Study | Lost to Follow-up | 9 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Investigational OTC Cream | Placebo Cream | 0.05% Desonide Cream | Total |
|---|---|---|---|---|
| Age, Continuous | 34.8 years STANDARD_DEVIATION 13.5 | 39.6 years STANDARD_DEVIATION 15.3 | 42 years STANDARD_DEVIATION 15.4 | 37.3 years STANDARD_DEVIATION 14.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 9 Participants | 6 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 9 Participants | 4 Participants | 32 Participants |
| Region of Enrollment United States | 36 participants | 18 participants | 11 participants | 65 participants |
| SCORAD | 49.18 units on a scale STANDARD_DEVIATION 2.39 | 52.21 units on a scale STANDARD_DEVIATION 3.36 | 45.22 units on a scale STANDARD_DEVIATION 4.33 | 49.3 units on a scale STANDARD_DEVIATION 14.1 |
| Sex: Female, Male Female | 25 Participants | 15 Participants | 7 Participants | 47 Participants |
| Sex: Female, Male Male | 11 Participants | 3 Participants | 4 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 18 | 0 / 11 |
| other Total, other adverse events | 2 / 36 | 2 / 18 | 0 / 11 |
| serious Total, serious adverse events | 0 / 36 | 0 / 18 | 0 / 11 |
Outcome results
Primary
Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis
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
Time frame: Baseline to Week 8
Population: Subjects with moderate Atopic Dermatitis as defined by Baseline SCORAD 25-40
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational OTC Cream | Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis | -12.2 units on a scale | Standard Error 3.99 |
| Placebo Cream | Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis | 9.3 units on a scale | Standard Error 6.51 |
| 0.05% Desonide Cream | Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis | -17.5 units on a scale | Standard Error 8.29 |
Comparison: Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.p-value: <0.05ANCOVA
Primary
Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis
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
Time frame: Baseline to Week 8
Population: Subjects with severe Atopic Dermatitis (Baseline SCORAD = 41+)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational OTC Cream | Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis | -6.0 units on a scale | Standard Error 2.8 |
| Placebo Cream | Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis | -20.3 units on a scale | Standard Error 3.7 |
| 0.05% Desonide Cream | Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis | -18.0 units on a scale | Standard Error 4.5 |
Comparison: Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.~Significance level: 0.05 (2-sided)p-value: <0.05ANCOVA