Dose Range Study of CD5789 in Acne Vulgaris
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ClinicalTrials.gov Identifier: NCT01616654 |
Recruitment Status
:
Completed
First Posted
: June 12, 2012
Last Update Posted
: February 11, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: CD5789 25 µg/g cream Drug: CD5789 50 µg/g cream Drug: CD5789 100 µg/g cream Drug: Tazarotene 0.1% gel Drug: Vehicle cream | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 304 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Multi-center, Investigator-blind, Vehicle- and Active-controlled, Phase 2 Study to Assess the Efficacy and Safety of Different Concentrations of CD5789 Cream Applied Once Daily in Subjects With Moderate to Severe Acne Vulgaris |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: CD5789 50 µg/g cream
CD5789 50 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3
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Drug: CD5789 50 µg/g cream
CD5789 50 µg/g cream applied once daily
|
Experimental: CD5789 100 µg/g cream
CD5789 100 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3
|
Drug: CD5789 100 µg/g cream
CD5789 100 µg/g cream applied once daily
|
Active Comparator: Tazarotene 0.1% gel
Tazarotene 0.1% gel applied once daily for subjects randomized in Stratum 1 and 2
|
Drug: Tazarotene 0.1% gel
Tazarotene 0.1% gel applied once daily
|
Placebo Comparator: Vehicle cream
Vehicle cream applied once daily for subjects randomized in Stratum 1, 2 and 3
|
Drug: Vehicle cream
Vehicle cream applied once daily
|
Experimental: CD5789 25 µg/g cream
CD5789 25 µg/g cream applied once daily for subjects randomized in Stratum 1, 2 and 3
|
Drug: CD5789 25 µg/g cream
CD5789 25 µg/g cream applied once daily
|
- Success Rate (IGA) [ Time Frame: up to Week 12 ]Defined as the percentage of subjects who achieve at least a two-point reduction in the IGA score from Baseline at Week 12, Last Observation Carried Forward (LOCF), Intent to Treat (ITT) population.
- Absolute change in total lesion counts [ Time Frame: Baseline to Week 12 ]Absolute change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules.
- Percent Change in total lesion counts [ Time Frame: Baseline to Week 12 ]Percent change in total lesion counts from Baseline to Week 12; total lesion counts is the sum of inflammatory, non-inflammatory lesions and nodules

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Ages Eligible for Study: | 12 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subject, 12 to 35 years old with the following characteristics:
-
Facial acne severity grade of the following:
- Stratum 1: IGA score of 3 or 4
- Stratum 2: IGA score of 4
- Stratum 3: IGA score of 3 or 4
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A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata:
- Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a maximum of one nodule on the face.
- Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.
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Stratum 3: Subjects of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.
- Note: Subjects of Japanese origin will not be included in Stratum 1 or Stratum 2. Japanese origin is defined as all four grandparents were born in Japan.
Exclusion Criteria:
- The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)
- Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject participates in the clinical trial.
- Known or suspected allergies or sensitivities to any components of any of the study drugs.
- Current participation in any other clinical trial of a drug or device OR past participation within the 30 days prior to the Baseline visit.

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): NCT01616654

Study Director: | Michael Graeber, M.D. | Galderma R&D, Inc. |
Responsible Party: | Galderma |
ClinicalTrials.gov Identifier: | NCT01616654 History of Changes |
Other Study ID Numbers: |
RD.06.SPR18223 |
First Posted: | June 12, 2012 Key Record Dates |
Last Update Posted: | February 11, 2014 |
Last Verified: | January 2014 |
Additional relevant MeSH terms:
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Tazarotene Nicotinic Acids Dermatologic Agents |
Keratolytic Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |