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

Galderma

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: CD2027 Ointment 3 mcg/g, twice daily; Drug: Vehicle Ointment, twice daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT00919763

RD.06.SPR.18158

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

CD2027 Ointment 3 mcg/g, twice daily

Experimental group

Description:

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.

Treatment:

Drug: CD2027 Ointment 3 mcg/g, twice daily

Vehicle Ointment, twice daily

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vehicle Ointment, twice daily