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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

CD1579 2.5%

CD1579 5%

Vehicle

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

Galderma investigational site
Galderma investigational site
Galderma investigational site
Galderma investigational site
Galderma investigational site
Galderma investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

CD1579 2.5%

CD1579 5%

Vehicle

Arm Description

Benzoyl Peroxide 2.5%

Benzoyl Peroxide 5%

Vehicle

Outcomes

Primary Outcome Measures

Percent Changes From Baseline in Total Lesion Counts

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

Secondary Outcome Measures

Percent of Subjects With Adverse Events

Adverse events which were observed in 5% or more patients with either group are listed.

Local Tolerability (Erythema)

Highest severity of local tolerability scores worse than Baseline

Local Tolerability (Scaling)

Highest severity of local tolerability scores worse than Baseline

Local Tolerability (Dryness)

Highest severity of local tolerability scores worse than Baseline

Local Tolerability (Pruritus)

Highest severity of local tolerability scores worse than Baseline

Local Tolerability (Stinging/Burning)

Highest severity of local tolerability scores worse than Baseline

Full Information

NCT ID

NCT02073461

First Posted

February 20, 2014

Last Updated

February 27, 2017

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT02073461

Brief Title

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

Official Title

A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

236 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CD1579 2.5%

Arm Type

Experimental

Arm Description

Benzoyl Peroxide 2.5%

Arm Title

CD1579 5%

Arm Type

Experimental

Arm Description

Benzoyl Peroxide 5%

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

Vehicle

Intervention Type

Drug

Intervention Name(s)

CD1579 2.5%

Other Intervention Name(s)

Benzoyl Peroxide 2.5%

Intervention Type

Drug

Intervention Name(s)

CD1579 5%

Other Intervention Name(s)

Benzoyl Peroxide 5%

Intervention Type

Drug

Intervention Name(s)

Vehicle

Primary Outcome Measure Information:

Title

Percent Changes From Baseline in Total Lesion Counts

Description

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

Time Frame

Baseline - Week 12

Secondary Outcome Measure Information:

Title

Percent of Subjects With Adverse Events

Description

Adverse events which were observed in 5% or more patients with either group are listed.

Time Frame

up to 12 weeks

Title

Local Tolerability (Erythema)

Description

Highest severity of local tolerability scores worse than Baseline

Time Frame

12 weeks

Title

Local Tolerability (Scaling)

Description

Highest severity of local tolerability scores worse than Baseline

Time Frame

12 weeks

Title

Local Tolerability (Dryness)

Description

Highest severity of local tolerability scores worse than Baseline

Time Frame

12 weeks

Title

Local Tolerability (Pruritus)

Description

Highest severity of local tolerability scores worse than Baseline

Time Frame

12 weeks

Title

Local Tolerability (Stinging/Burning)

Description

Highest severity of local tolerability scores worse than Baseline

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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

Facility Information:

Facility Name

Galderma investigational site

City

Amagasaki

State/Province

Hyogo

Country

Japan

Facility Name

Galderma investigational site

City

Kobe

State/Province

Hyogo

Country

Japan

Facility Name

Galderma investigational site

City

Nakano

State/Province

Tokyo

Country

Japan

Facility Name

Galderma investigational site

City

Shibuya

State/Province

Tokyo

Country

Japan

Facility Name

Galderma investigational site

City

Shinjuku

State/Province

Tokyo

Country

Japan

Facility Name

Galderma investigational site

City

Fukuoka

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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