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Completed

NCT Number: NCT03034460

Efficacy and Safety of CD5024 1% in Acne Vulgaris

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Galderma Investigational Site (# 8060), Windsor, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is a male or a female aged from 18 to 35 years old at screening visit.
  • 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

  • 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

  • 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).
  • The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
  • 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).
  • The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).

Treatment and study plan

CD5024 1% cream

Drug

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

CD5024 cream placebo

Drug

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

CD0271/CD1579 gel

Drug

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

CD0271/CD1579 gel placebo

Drug

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

Primary outcomes

  1. Inflammatory Lesion Count (Papules and Pustules) at Day 40

    Time frame: Day 40

    Inflammatory lesion count corresponded to the sum of papules and pustules.

Secondary outcomes

  1. Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)

    Time frame: Baseline (Day 1)

    Inflammatory lesion count corresponded to the sum of papules and pustules.

  2. Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40

    Time frame: Baseline (Day 1), and Day 40

    Inflammatory lesion count corresponded to the sum of papules and pustules.

  3. Total Lesion Count at Baseline (Day 1) and Day 40

    Time frame: Baseline (Day 1), and Day 40

    Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.

  4. Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40

    Time frame: Baseline (Day 1), and Day 40

    Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.

  5. Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40

    Time frame: Baseline (Day 1), and Day 40

    Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.

  6. Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40

    Time frame: Baseline (Day 1), and Day 40

    Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.

  7. Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40

    Time frame: Day 40

    The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.

  8. Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40

    Time frame: Day 40

    The participants gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.

  9. Number of Participants With Adverse Events (AEs)

    Time frame: From start of study up to follow up (Week 7)

    AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  10. Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)

    Time frame: From Day 1 up Follow up (Week 7)

    Signs and symptoms of local cutaneous irritation(local tolerability [erythema, scaling, dryness, stinging/burning, pruritus]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Number of participants reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 27, 2017
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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