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Efficacy and Safety of CD5024 1% in Acne Vulgaris

NCT ID: NCT03034460

Last Updated: 2020-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-25

Study Completion Date

2016-11-02

Brief Summary

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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.

Detailed Description

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

Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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CD5024 1% cream

Active drug;

Group Type EXPERIMENTAL

CD5024 1% cream

Intervention Type DRUG

500 µL on half-face, five days a week during 6 weeks

CD5024 cream placebo

Placebo of active drug;

Group Type PLACEBO_COMPARATOR

CD5024 cream placebo

Intervention Type DRUG

500 µL on half-face, five days a week during 6 weeks

CD0271/CD1579 gel

Positive control;

Group Type OTHER

CD0271/CD1579 gel

Intervention Type DRUG

500 µL on half-face, five days a week during 6 weeks

CD0271/CD1579 gel placebo

Placebo of positive control;

Group Type OTHER

CD0271/CD1579 gel placebo

Intervention Type DRUG

500 µL on half-face, five days a week during 6 weeks

Interventions

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CD5024 1% cream

500 µL on half-face, five days a week during 6 weeks

Intervention Type DRUG

CD5024 cream placebo

500 µL on half-face, five days a week during 6 weeks

Intervention Type DRUG

CD0271/CD1579 gel

500 µL on half-face, five days a week during 6 weeks

Intervention Type DRUG

CD0271/CD1579 gel placebo

500 µL on half-face, five days a week during 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Galderma Investigational Site (# 8060)

Windsor, Ontario, Canada

Site Status

Galderma Investigational site

Montreal, Quebec, Canada

Site Status

Galderma investigational site

Nantes, , France

Site Status

Galderma investigational site

Nice, , France

Site Status

Galderma investigational site

Berlin, , Germany

Site Status

Galderma investigational site

Bochum, , Germany

Site Status

Galderma investigational site

Münster, , Germany

Site Status

Countries

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Canada France Germany

Other Identifiers

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RD.03.SPR.109807

Identifier Type: -

Identifier Source: org_study_id