Efficacy and Safety Study of CD2027 Ointment 3 mcg/g Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is 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 subjects 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% - 20% involved BSA (excluding Head/Neck) in adult subjects with at least moderate atopic dermatitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D

Criteria

Inclusion Criteria:

• Male or female subject, 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:is representative of the subject's disease state,is not located on the hands, feet or genitalia,measures at least 10 cm²,presents 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 subject has albumin-adjusted calcium above the upper normal range from screening evaluation.

• The subject has history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget's disease, adrenal insufficiency, hyperthyroidism)

• The subject has signs/symptoms of urinary stones or has a history of urinary stones within the past 5 years prior to the Screening Visit