Efficacy and Safety of CD5024 1% in Acne Vulgaris

NCT03034460 | Completed Phase 2 Results

• 1 other identifier: RD.03.SPR.109807
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 7

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Inflammatory Lesion Count (Papules and Pustules) at Day 40

  Inflammatory lesion count corresponded to the sum of papules and pustules.

  Day 40

Secondary Outcomes (10)

• Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)

  Baseline (Day 1)

• Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40

  Baseline (Day 1), and Day 40

• Total Lesion Count at Baseline (Day 1) and Day 40

  Baseline (Day 1), and Day 40

• Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40

  Baseline (Day 1), and Day 40

• Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40

  Baseline (Day 1), and Day 40

Study Arms (4)

CD5024 1% cream

EXPERIMENTAL

Active drug;

Drug: CD5024 1% cream

CD5024 cream placebo

PLACEBO COMPARATOR

Placebo of active drug;

Drug: CD5024 cream placebo

CD0271/CD1579 gel

OTHER

Positive control;

Drug: CD0271/CD1579 gel

CD0271/CD1579 gel placebo

OTHER

Placebo of positive control;

Drug: CD0271/CD1579 gel placebo

Interventions

CD5024 1% cream DRUG

500 µL on half-face, five days a week during 6 weeks

CD5024 1% cream

CD5024 cream placebo DRUG

500 µL on half-face, five days a week during 6 weeks

CD5024 cream placebo

CD0271/CD1579 gel DRUG

500 µL on half-face, five days a week during 6 weeks

CD0271/CD1579 gel

CD0271/CD1579 gel placebo DRUG

500 µL on half-face, five days a week during 6 weeks

CD0271/CD1579 gel placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is a male or a female aged from 18 to 35 years old at screening visit.
• The subject has a medical diagnosis of acne vulgaris :
• 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
• symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side at Baseline
• If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study

You may not qualify if:

• 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).
• The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
• 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).
• The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (7)

Galderma Investigational Site (# 8060)

Windsor, Ontario, N8W 5L7, Canada

Location

Galderma Investigational site

Montreal, Quebec, Canada

Location

Galderma investigational site

Nantes, France

Location

Galderma investigational site

Nice, France

Location

Galderma investigational site

Berlin, Germany

Location

Galderma investigational site

Bochum, Germany

Location

Galderma investigational site

Münster, Germany

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: January 27, 2017
• Study Start: April 25, 2016
• Primary Completion: November 2, 2016
• Study Completion: November 2, 2016
• Last Updated: December 11, 2020
• Results First Posted: December 11, 2020

Record last verified: 2017-01

Locations

CA (2); DE (3); FR (2)