Clinical trial NCT03034460: Efficacy and Safety of CD5024 1% in Acne Vulgaris
Official title: Efficacy and Safety of CD5024 1% in Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-01-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.

Detailed description: Study drugs application will be performed once daily, 5 days a week during 6 weeks

Eligibility criteria: Inclusion Criteria:

1. The subject is a male or a female aged from 18 to 35 years old at screening visit.
2. The subject has a medical diagnosis of acne vulgaris :

   2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) at Baseline

   2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side at Baseline
3. If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study

Exclusion Criteria:

1. The subject has an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (Screening).
2. The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
3. The subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure/Product label).
4. The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).

Primary outcomes:
measure: Inflammatory Lesion Count (Papules and Pustules) at Day 40
timeFrame: Day 40
Secondary outcomes:
measure: Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)
timeFrame: Baseline (Day 1)
measure: Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40
timeFrame: Baseline (Day 1), and Day 40
measure: Total Lesion Count at Baseline (Day 1) and Day 40
timeFrame: Baseline (Day 1), and Day 40
measure: Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40
timeFrame: Baseline (Day 1), and Day 40
measure: Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40
timeFrame: Baseline (Day 1), and Day 40
measure: Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40
timeFrame: Baseline (Day 1), and Day 40
measure: Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40
timeFrame: Day 40
measure: Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40
timeFrame: Day 40
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From start of study up to follow up (Week 7)
measure: Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)
timeFrame: From Day 1 up Follow up (Week 7)
Other outcomes:
Locations:
city: Windsor
country: Canada
facility: Galderma Investigational Site (# 8060)
state: Ontario
city: Montreal
country: Canada
facility: Galderma Investigational site
state: Quebec
city: Nantes
country: France
facility: Galderma investigational site
city: Nice
country: France
facility: Galderma investigational site
city: Berlin
country: Germany
facility: Galderma investigational site
city: Bochum
country: Germany
facility: Galderma investigational site
city: Munster
country: Germany
facility: Galderma investigational site
Study officials:
References: