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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT00919763
First received: June 9, 2009
Last updated: May 29, 2012
Last verified: May 2012
History of Changes

June 9, 2009
May 29, 2012
May 2009
October 2009   (final data collection date for primary outcome measure)
Total Sum Score (TSS)of Target Lesion [ Time Frame: at Week 4 ] [ Designated as safety issue: No ]

Total Sum Score (TSS) on the Target Lesion at Week 4 or Early Termination adjusted on Baseline (Sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification of Target Lesion).

Scale values range from 0 - 3; 0 is minumal (best) and 3 is maximum (worst). Unit is used as score on a scale. Total possible minimum score is 0. Total possible maximum score is 15.
Total sum score (TSS)of target lesion [ Time Frame: at Week 4 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00919763 on ClinicalTrials.gov Archive Site
Percent Change in TSS [ Time Frame: from Baseline to Week 4 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of CD2027 Ointment 3 Mcg/g Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: CD 2027
    Topical Ointment; two applications daily, once in the morning and once in the evening for 4 weeks
  • Drug: CD 2027 Vehicle
    Topical Ointment, two applications daily, once in the morning and once in the evening for 4 weeks
  • Experimental: CD 2027
    Topical Ointment
    Intervention: Drug: CD 2027
  • Placebo Comparator: CD 2027 Vehicle
    Topical Ointment
    Intervention: Drug: CD 2027 Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
November 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00919763
RD.06.SPR.18158
No
Galderma
Galderma
Not Provided
Study Director: Michael Graeber, MD Galderma
Galderma
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP