Acne Vulgaris MedDRA version: 19.0 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Code: CD5789
Pharmaceutical Form: Cream
INN or Proposed INN: Trifarotene
CAS Number: 895542-09-3
Current Sponsor code: CD5789
Concentration type: equal
Concentration number: 50 µg/g-
Sponsors
Galderma R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, 9 years of age and older at Screening visit. - The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits. - The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face. - The subject has truncal acne severity grade of PGA 3 (moderate) at Screening and Baseline visits on the shoulders, anterior chest and upper back reachable to self-application of study drug by the subject (this inclusion criterion is optional for children between 9 and 11 years old). - The subject has a minimum of 20 inflammatory lesions and 20 noninflammatory lesions at Screening and Baseline visits on the shoulders, upper back and anterior chest (this inclusion criterion is optional for children between 9 and 11 years old). Are the trial subjects under 18? yes Number of subjects for this age range: 110 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 39 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.). - The Subject has more than 1 nodule on the face at Screening and at Baseline visits. - The Subject has more than 1 nodule on the trunk at Screening and at Baseline visits. - The Subject has any acne cyst on the face at Screening and at Baseline visits. - The Subject has any acne cyst on the trunk at Screening and at Baseline visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and efficacy of CD5789 50µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris.;Secondary Objective: Efficacy will be evaluated as a secondary objective.;Primary end point(s): Safety: 1- assessment of local tolerability on treated areas and adverse events, 2- vital signs and physical eamination, 3- and laboratory tests;Timepoint(s) of evaluation of this end point: 1- at each visit 2- at Screening, baseline, WE12, W26 and W52 3- at Screening, baseline, W26 and W52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: at each time point;Secondary end point(s): Efficacy : - success rate of IGA, - success rate of PGA, - grade change from baseline of PGA, - grade change from baseline of IGA, - subject's assessement | — |
Countries
Czech Republic, Germany, Hungary, United States
Contacts
Public ContactCTA Coordinator
Galderma R&D SNC
Outcome results
None listed