Dose Range Study of CD5789 in Acne Vulgaris

Galderma

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Vehicle cream; Drug: CD5789 50 µg/g cream; Drug: Tazarotene 0.1% gel; Drug: CD5789 25 µg/g cream; Drug: CD5789 100 µg/g cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01616654

RD.06.SPR.18223

Details and patient eligibility

About

To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.

Enrollment: 304 patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participant, 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

• 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.

  • Stratum 3: Participants of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.

    • Note: Participants 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 participant at significant risk (according to the Investigator's judgment) if the participant 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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304 participants in 5 patient groups, including a placebo group

CD5789 25 mcg/g Cream

Experimental group

Description:

Participants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks.

Treatment:

Drug: CD5789 25 µg/g cream

CD5789 50 mcg/g Cream

Experimental group

Description:

Participants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks.

Treatment:

Drug: CD5789 50 µg/g cream

CD5789 100 mcg/g Cream

Active Comparator group

Description:

Participants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks.

Treatment:

Drug: CD5789 100 µg/g cream

Tazarotene 0.1% Gel

Placebo Comparator group

Description:

Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.

Treatment:

Drug: Tazarotene 0.1% gel

Vehicle Cream

Experimental group

Description:

Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.

Treatment:

Drug: Vehicle cream