Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of CD5024 1% in 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: NCT03034460
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

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.

Condition or disease Intervention/treatment Phase
Acne Drug: CD5024 1% cream Drug: CD5024 cream placebo Drug: CD0271/CD1579 gel Drug: CD0271/CD1579 gel placebo Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Efficacy and Safety of CD5024 1% in Acne Vulgaris
Study Start Date : April 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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

CD0271/CD1579 gel
Positive control;
Drug: CD0271/CD1579 gel
500 µL on half-face, five days a week during 6 weeks

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




Primary Outcome Measures :
  1. Inflammatory acne lesion count per half face [ Time Frame: Day 40 ]


Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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): NCT03034460


Locations
Layout table for location information
Canada, Ontario
Galderma Investigational Site (# 8060)
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Galderma Investigational site
Montreal, Quebec, Canada
France
Galderma investigational site
Nantes, France
Galderma investigational site
Nice, France
Germany
Galderma investigational site
Berlin, Germany
Galderma investigational site
Bochum, Germany
Galderma investigational site
Munster, Germany
Sponsors and Collaborators
Galderma R&D

Layout table for additonal information
Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT03034460     History of Changes
Other Study ID Numbers: RD.03.SPR.109807
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases