Atopic Dermatitis MedDRA version: 9.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Product Code: CD2027
Pharmaceutical Form: Ointment
INN or Proposed INN: CALCITRIOL
CAS Number: 32222-06-03
Current Sponsor code: CD2027
Concentration unit: % (W/W) percent weight/weight
Concentration
Sponsors
Galderma R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is a male or female, 18 years of age or older 2. The subject has a clinical diagnosis of Atopic dermatitis according to the Hanifin and Rajka criteria 3. The subject has at least two equivalent symmetrical target lesions of Atopic dermatitis localized on comparable body areas (left/right) which: - Are between 20 and 200 cm² (approximately 1% of BSA) - Have not more that a 2-fold difference in size - Are not located on the hands, feet, genitalia or face - Present a total severity score of at least 6/15 (total score defined as the sum of erythema, papulation/induration, oozing/crusting, excoriation, lichenification) with oozing/crusting score = 1. - Are of similar severity (severity of the two target lesions does not differ by more than 1 point based on the TSS score ) - Have a Pruritus score = 2 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: 1. The subject is a pregnant or lactating female 2. The subject is a female who intends to conceive a child within 2 months following baseline visit 3. The subject has history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget’s disease, adrenal insufficiency, hyperthyroidism…) 4. The subject has signs and symptoms of urinary stones 5. The subject has had urinary stones since the past 5 year before screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of CD2027 ointment 9µg/g applied twice daily over 4 weeks versus its vehicle on target lesions in adult subjects with Atopic dermatitis.;Secondary Objective: ;Primary end point(s): The primary criterion is the Total Sum Score on target lesion (sum of individual clinical scores of erythema, excoriation, papulation/induration, oozing/crusting and lichenification) | — |
Countries
France, Hungary
Outcome results
None listed