Atopic Dermatitis MedDRA version: 9.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Product Code: CD4802
Pharmaceutical Form: Ointment
Current Sponsor code: CD4802
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: O
Sponsors
GALDERMA R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The subject is a male or female 18 years of age or older, - The subject is a female of non-childbearing potential, e.g. postmenopausal (absence of menstrual bleeding for 2 years), or had a hysterectomy or bilateral ovariectomy, - The subject has a clinical diagnosis of chronic atopic dermatitis according to Hanifin and Rajka (1980), mild to moderate in intensity as defined by Langeland and Rajka (1989). - The subject presents at least 2 symmetric plaques which: - Are representative of the subject’s disease state, - Are of similar severity, - Represent a surface comprised between 10 and 30 cm² (+/- 2) - Are not located on the hands, feet, genitalia or face, - Present a total score of at least 5/15 (total score defined as the sum of erythema, oedema/papulation, excoriation, lichenification, and oozing/crusting graded on a scale of 0 to 3 (maximum total score = 15) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Underlying disease, which, in the investigator’s opinion would put the subject at risk (e.g., uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial such as cancer, AIDS, severe cardiopathy, renal or hepatic impairment…) - Underlying dermatological disease, which, in the investigator’s opinion, may confound the study assessment (e.g., other dermatological diseases affecting the treatment areas, such as psoriasis, severe ichtyosis, exfoliative erythrodermia, impetiginized atopic dermatitis…) - Corrected serum calcium concentration above upper normal range at screening visit - Calcium/creatinine ratio in urines above upper normal range at screening visit - History/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget’s disease, adrenal insufficiency, hyperthyroidism…), - History/signs/symptoms of urinary stones, - History of cancer including skin cancer, - Positive HIV, HBV or HCV serology, - Clinically significant abnormalities discovered in the blood and urinary tests performed at the screening visit, - Planned exposure to sun or ultraviolet light during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of CD4802 ointment 0.1% over 4 weeks versus vehicle on target lesions in adult patients with atopic dermatitis.;Secondary Objective: Evaluate the safety of CD4802 ointment 0.1% in patients with atopic dermatitis: - Local tolerance by AEs, - Systemic tolerance by AEs, vital signs, laboratory tests Characterize the pathology and response to treatment by proteomic and genomic analysis conducted on skin strippings and saliva samplings, respectively.;Primary end point(s): The primary criterion is the Area under the curve (AUC) for Total Sum Score (sum of individual clinical scores: erythema + excoriation + oedema/papulation + oozing/crusting + lichenification) calculated from D 1/Baseline (before application) up to D29 by subject and by treatment, using the trapezoidal rule. | — |
Countries
France
Outcome results
None listed