Efficacy and Safety of CD5024 1% in Acne Vulgaris

Acne Clinical Trial

Official title:

Efficacy and Safety of CD5024 1% in Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034460
• Other study ID #: RD.03.SPR.109807
• Status: Completed
• Phase: Phase 2
• Start date: April 25, 2016
• Est. completion date: November 2, 2016

Study information

• Verified date: January 2017
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2, 2016
• Est. primary completion date: November 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• CD5024 1% cream
500 µL on half-face, five days a week during 6 weeks
• CD5024 cream placebo
500 µL on half-face, five days a week during 6 weeks
• CD0271/CD1579 gel
500 µL on half-face, five days a week during 6 weeks
• CD0271/CD1579 gel placebo
500 µL on half-face, five days a week during 6 weeks

Locations

Country	Name	City	State
Canada	Galderma Investigational site	Montreal	Quebec
Canada	Galderma Investigational Site (# 8060)	Windsor	Ontario
France	Galderma investigational site	Nantes
France	Galderma investigational site	Nice
Germany	Galderma investigational site	Berlin
Germany	Galderma investigational site	Bochum
Germany	Galderma investigational site	Munster

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

Canada,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory Lesion Count (Papules and Pustules) at Day 40	Inflammatory lesion count corresponded to the sum of papules and pustules.	Day 40
Secondary	Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)	Inflammatory lesion count corresponded to the sum of papules and pustules.	Baseline (Day 1)
Secondary	Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40	Inflammatory lesion count corresponded to the sum of papules and pustules.	Baseline (Day 1), and Day 40
Secondary	Total Lesion Count at Baseline (Day 1) and Day 40	Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.	Baseline (Day 1), and Day 40
Secondary	Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40	Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.	Baseline (Day 1), and Day 40
Secondary	Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40	Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.	Baseline (Day 1), and Day 40
Secondary	Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40	Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.	Baseline (Day 1), and Day 40
Secondary	Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40	The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.	Day 40
Secondary	Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40	The participants gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.	Day 40
Secondary	Number of Participants With Adverse Events (AEs)	AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	From start of study up to follow up (Week 7)
Secondary	Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)	Signs and symptoms of local cutaneous irritation(local tolerability [erythema, scaling, dryness, stinging/burning, pruritus]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Number of participants reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported.	From Day 1 up Follow up (Week 7)