Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02073448 |
Recruitment Status :
Completed
First Posted : February 27, 2014
Results First Posted : November 3, 2016
Last Update Posted : March 28, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: GK530G Drug: CD0271 Drug: CD1579 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 417 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-blinded, Active-controlled Parallel Group Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris. |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: GK530G
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
|
Drug: GK530G
Other Name: Fixed-dose combination gel of Adapalene and Benzoyl Peroxide |
Active Comparator: CD0271
Adapalene 01% Gel
|
Drug: CD0271
Other Name: Adapalene 0.1% Gel |
Active Comparator: CD1579
Benzoyl Peroxide 2.5% Gel
|
Drug: CD1579
Other Name: Benzoyl Peroxide 2.5% Gel |
- Percent Changes From Baseline in Total Lesion Counts [ Time Frame: Baseline - Week12 ]
- Percent of Subjects With Adverse Events [ Time Frame: up to 12 weeks ]
- Local Tolerability (Erythema) [ Time Frame: 12 weeks ]Highest severity of local tolerability scores worse than Baseline
- Local Tolerability (Scaling) [ Time Frame: 12 weeks ]Highest severity of local tolerability scores worse than Baseline
- Local Tolerability (Dryness) [ Time Frame: 12 weeks ]Highest severity of local tolerability scores worse than Baseline
- Local Tolerability (Pruritus) [ Time Frame: 12 weeks ]Highest severity of local tolerability scores worse than Baseline
- Local Tolerability (Stinging/Burning) [ Time Frame: 12 weeks ]Highest severity of local tolerability scores worse than Baseline

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073448
Japan | |
Galderma investigational site | |
Chitose, Hokkaido, Japan | |
Galderma investigational site | |
Kitami, Hokkaido, Japan | |
Galderma investigational site | |
Sapporo, Hokkaido, Japan | |
Galderma investigational site | |
Yokohama, Kanagawa, Japan | |
Galderma investigational site | |
Kurashiki, Okayama, Japan | |
Galderma investigational site | |
Daito, Osaka, Japan | |
Galderma investigational site | |
Neyagawa, Osaka, Japan | |
Galderma investigational site | |
Sakai, Osaka, Japan | |
Galderma investigational site | |
Adachi, Tokyo, Japan | |
Galderma investigational site | |
Setagaya, Tokyo, Japan | |
Galderma investigational site | |
Kagoshima, Japan | |
Galderma investigational site | |
Osaka, Japan | |
Galderma investigational site | |
Saitama, Japan |
Responsible Party: | Galderma R&D |
ClinicalTrials.gov Identifier: | NCT02073448 |
Other Study ID Numbers: |
RDT.07.SPR.27123 |
First Posted: | February 27, 2014 Key Record Dates |
Results First Posted: | November 3, 2016 |
Last Update Posted: | March 28, 2017 |
Last Verified: | February 2017 |
Acne Vulgaris |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Adapalene Benzoyl Peroxide Dermatologic Agents Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |