A Four-Week, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CD2027 Ointment 3 mcg/g Twice Daily in the Treatment of Adults With at Least Moderate Atopic Dermatitis
Overview
- Phase
- Phase 2
- Intervention
- CD2027 Ointment 3 mcg/g, twice daily
- Conditions
- Atopic Dermatitis
- Sponsor
- Galderma R&D
- Enrollment
- 102
- Locations
- 14
- Primary Endpoint
- Total Severity Score (TSS) of Target Lesion at Baseline and Week 4
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives: To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis.
Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over 4 weeks versus its vehicle on 5 percent (%) - 20% involved Body Surface Area (BSA) (excluding Head/Neck) in adult participants with at least moderate atopic dermatitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female participant, 18 years of age or older
- •Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka criteria, of at least moderate intensity according to Investigator Global Assessment (IGA greater or equal to 3)
- •Body surface affected by the disease between 5% and 20% of total BSA, based on Rule of Nine's, excluding Head/Neck
- •At least one area (Target Lesion) which was representative of the participant's disease state, was not located on the hands, feet or genitalia, measures at least 10 cm\^2, presented a Total Severity Score of at least 6/15 (total severity score defined as the sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification) with oozing/crusting severity at most 1
Exclusion Criteria
- •The participant had albumin-adjusted calcium above the upper normal range from screening evaluation
- •The participant had history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget's disease, adrenal insufficiency, hyperthyroidism)
- •The participant had signs/symptoms of urinary stones or has a history of urinary stones within the past 5 years prior to the Screening Visit
Arms & Interventions
CD2027 Ointment 3 mcg/g, twice daily
Participants applied 3 mcg/g CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions.
Intervention: CD2027 Ointment 3 mcg/g, twice daily
Vehicle Ointment, twice daily
Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions.
Intervention: Vehicle Ointment, twice daily
Outcomes
Primary Outcomes
Total Severity Score (TSS) of Target Lesion at Baseline and Week 4
Time Frame: Baseline, Week 4
TSS comprised of the sum of an assessment of erythema, excoriation, exudation, lichenification and pruritus, each on a scale of 0 to 3 to give a maximum score of 15; 0 (best) and 3 (worst) indicated total possible minimum score was 0 and total possible maximum score was 15. Lower score meant improvement in condition and higher score indicated worsening of condition.
Secondary Outcomes
- Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4(Baseline, Week 4)
- Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Failure From Baseline of Greater Than 1 Points Over Week 4(Baseline, Week 1, Week 2, Week 3, Week 4)
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4(Baseline, Week1, Week2, Week 3, Week 4)