EUCTR2014-001755-23-CZActive, not recruitingPhase 1
A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 50µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS - CD5789 Long Term Study (LTS) on acne vulgaris
Galderma R&D SNC0 sites450 target enrollmentStarted: September 11, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 450
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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: 108
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
Investigators
Similar Trials
Active, not recruiting
Phase 1
A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 50µg/g CREAM IN SUBJECTS WITH ACNE VULGARISAcne VulgarisMedDRA version: 19.0Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858EUCTR2014-001755-23-HUGalderma R&D SNC450
Completed
Phase 3
CD5789 (Trifarotene) Long Term Safety Study on Acne VulgarisAcne VulgarisNCT02189629Galderma R&D453
Active, not recruiting
Not Applicable
A randomized long-term safety study of Org 50081 in elderly outpatients with chronic primary insomnia examining the effects of 1.5 mg or 3.0 mg of Org 50081 - JADEPrimary insomniaMedDRA version: 9.1Level: LLTClassification code 10036701Term: Primary insomniaEUCTR2007-003636-35-NLV Organon250
Active, not recruiting
Not Applicable
A randomized long-term safety study of Org 50081 in elderly outpatients with chronic primary insomnia examining the effects of 1.5 mg or 3.0 mg of Org 50081 - JADEEUCTR2007-003636-35-DEV Organon250
Active, not recruiting
Not Applicable
A randomized long-term safety study of Org 50081 in elderly outpatients with chronic primary insomnia examining the effects of 1.5 mg or 3.0 mg of Org 50081 - JADEPrimary insomniaMedDRA version: 9.1Level: LLTClassification code 10036701Term: Primary insomniaEUCTR2007-003636-35-SEV Organon250