Efficacy and Safety of CD5024 1% in Acne Vulgaris

Galderma

Status and phase: Completed; Phase 2

Conditions: Acne

Treatments: Drug: CD5024 1% cream; Drug: CD0271/CD1579 gel; Drug: CD5024 cream placebo; Drug: CD0271/CD1579 gel placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03034460

RD.03.SPR.109807

Details and patient eligibility

About

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.

Full description

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

Enrollment: 70 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 4 patient groups, including a placebo group

CD5024 1% cream

Experimental group

Description:

Active drug;

Treatment:

Drug: CD5024 1% cream

CD5024 cream placebo

Placebo Comparator group

Description:

Placebo of active drug;

Treatment:

Drug: CD5024 cream placebo

CD0271/CD1579 gel

Other group

Description:

Positive control;

Treatment:

Drug: CD0271/CD1579 gel

CD0271/CD1579 gel placebo

Other group

Description:

Placebo of positive control;

Treatment:

Drug: CD0271/CD1579 gel placebo