Efficacy and Safety of CD5024 1% in Acne Vulgaris

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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: CD5024 1% cream; Drug: CD5024 cream placebo; Drug: CD0271/CD1579 gel; Drug: CD0271/CD1579 gel placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Windsor, Ontario, Canada, N8W 5L7
      • Galderma Investigational Site (# 8060)
  • Quebec
    • Montreal, Quebec, Canada
      • Galderma Investigational Site
• France
  • Nantes, France
    • Galderma Investigational Site
  • Nice, France
    • Galderma Investigational Site
• Germany
  • Berlin, Germany
    • Galderma Investigational Site
  • Bochum, Germany
    • Galderma Investigational Site
  • Munster, Germany
    • Galderma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD5024 1% cream; Active drug;	Drug: CD5024 1% cream; 500 µL on half-face, five days a week during 6 weeks
Placebo Comparator: CD5024 cream placebo; Placebo of active drug;	Drug: CD5024 cream placebo; 500 µL on half-face, five days a week during 6 weeks
Other: CD0271/CD1579 gel; Positive control;	Drug: CD0271/CD1579 gel; 500 µL on half-face, five days a week during 6 weeks
Other: CD0271/CD1579 gel placebo; Placebo of positive control;	Drug: CD0271/CD1579 gel placebo; 500 µL on half-face, five days a week during 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Lesion Count (Papules and Pustules) at Day 40	Inflammatory lesion count corresponded to the sum of papules and pustules.	Day 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)	Inflammatory lesion count corresponded to the sum of papules and pustules.	Baseline (Day 1)
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
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
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
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
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
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
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
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)
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)

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2016
• Primary Completion (Actual): November 2, 2016
• Study Completion (Actual): November 2, 2016

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: RD.03.SPR.109807