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

NCT00919763 | Completed Phase 2 Results

• 1 other identifier: RD.06.SPR.18158
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 14

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.

Conditions

Atopic Dermatitis

Keywords

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Total Severity Score (TSS) of Target Lesion at Baseline and 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.

  Baseline, Week 4

Secondary Outcomes (3)

• 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

Study Arms (2)

CD2027 Ointment 3 mcg/g, twice daily

EXPERIMENTAL

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.

Drug: CD2027 Ointment 3 mcg/g, twice daily

Vehicle Ointment, twice daily

PLACEBO COMPARATOR

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.

Drug: Vehicle Ointment, twice daily

Interventions

CD2027 Ointment 3 mcg/g, twice daily DRUG

Topical Ointment

CD2027 Ointment 3 mcg/g, twice daily

Vehicle Ointment, twice daily DRUG

Topical Ointment

Vehicle Ointment, twice daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (14)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Therapeutics Clinical Research, Inc.

San Diego, California, 92123, United States

Location

Colorado Medical Research Center, Inc.

Denver, Colorado, 80120, United States

Location

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Dermatology Specialists PSC

Louisville, Kentucky, 40202, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Helendale Dermatology & Medical Spa, LLC

Rochester, New York, 104609, United States

Location

Oregon Dermatology & Research Center

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

DermResearch Inc.

Austin, Texas, 78759, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

8179615000

Study Officials

• Michael Graeber, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 12, 2009
• Study Start: May 21, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 19, 2022
• Results First Posted: May 1, 2012

Record last verified: 2022-05

Locations

US (14)