Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

NCT02073461 | Completed Phase 2 Results

• 1 other identifier: RDT.07.SPR.27124
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 6

Brief Summary

This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Percent Changes From Baseline in Total Lesion Counts

  Median percent reductions from Baseline in total lesion count (ITT-LOCF)

  Baseline - Week 12

Secondary Outcomes (6)

• Percent of Subjects With Adverse Events

  up to 12 weeks

• Local Tolerability (Erythema)

  12 weeks

• Local Tolerability (Scaling)

  12 weeks

• Local Tolerability (Dryness)

  12 weeks

• Local Tolerability (Pruritus)

  12 weeks

Study Arms (3)

CD1579 2.5%

EXPERIMENTAL

Benzoyl Peroxide 2.5%

Drug: CD1579 2.5%

CD1579 5%

EXPERIMENTAL

Benzoyl Peroxide 5%

Drug: CD1579 5%

Vehicle

PLACEBO COMPARATOR

Vehicle

Drug: Vehicle

Interventions

CD1579 2.5% DRUG

Also known as: Benzoyl Peroxide 2.5%

CD1579 2.5%

CD1579 5% DRUG

Also known as: Benzoyl Peroxide 5%

CD1579 5%

Vehicle DRUG

Vehicle

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women at the age of 12 or older at the Screening visit.
• Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

You may not qualify if:

• Those with more than two nodular acne lesions or any cysts.
• Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
• Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (6)

Galderma investigational site

Fukuoka, Fukuoka, Japan

Location

Galderma investigational site

Amagasaki, Hyōgo, Japan

Location

Galderma investigational site

Kobe, Hyōgo, Japan

Location

Galderma investigational site

Nakano City, Tokyo, Japan

Location

Galderma investigational site

Shibuya City, Tokyo, Japan

Location

Galderma investigational site

Shinjuku, Tokyo, Japan

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 Project Manager
• Organization: Galderma K.K.

GaldermaKK.ClinDev@galderma.com

+81 3 5937 3850

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 27, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 28, 2017
• Results First Posted: November 3, 2016

Record last verified: 2017-02

Locations

JP (6)