Back to resultsEfficacy and Safety of CD5024 1% in Acne Vulgaris
Primary Purpose
Acne
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CD5024 1% cream
CD5024 cream placebo
CD0271/CD1579 gel
CD0271/CD1579 gel placebo
Sponsored by
About this trial
This is an interventional other trial for Acne
Eligibility Criteria
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).
Sites / Locations
- Galderma Investigational Site (# 8060)
- Galderma Investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
- Galderma investigational site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Other
Other
Arm Label
CD5024 1% cream
CD5024 cream placebo
CD0271/CD1579 gel
CD0271/CD1579 gel placebo
Arm Description
Active drug;
Placebo of active drug;
Positive control;
Placebo of positive control;
Outcomes
Primary Outcome Measures
Inflammatory Lesion Count (Papules and Pustules) at Day 40
Inflammatory lesion count corresponded to the sum of papules and pustules.
Secondary Outcome Measures
Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)
Inflammatory lesion count corresponded to the sum of papules and pustules.
Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40
Inflammatory lesion count corresponded to the sum of papules and pustules.
Total Lesion Count at Baseline (Day 1) and Day 40
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.
Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.
Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40
Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.
Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40
Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.
Number of Participants Reported for Investigator's Preference on a 5-Point Scale at 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.
Number of Participants Reported for Participant's Preference on 5-Point Scale at 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.
Number of Participants With Adverse Events (AEs)
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.
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03034460
Brief Title
Efficacy and Safety of CD5024 1% in Acne Vulgaris
Official Title
Efficacy and Safety of CD5024 1% in Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 25, 2016 (Actual)
Primary Completion Date
November 2, 2016 (Actual)
Study Completion Date
November 2, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Study drugs application will be performed once daily, 5 days a week during 6 weeks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD5024 1% cream
Arm Type
Experimental
Arm Description
Active drug;
Arm Title
CD5024 cream placebo
Arm Type
Placebo Comparator
Arm Description
Placebo of active drug;
Arm Title
CD0271/CD1579 gel
Arm Type
Other
Arm Description
Positive control;
Arm Title
CD0271/CD1579 gel placebo
Arm Type
Other
Arm Description
Placebo of positive control;
Intervention Type
Drug
Intervention Name(s)
CD5024 1% cream
Intervention Description
500 µL on half-face, five days a week during 6 weeks
Intervention Type
Drug
Intervention Name(s)
CD5024 cream placebo
Intervention Description
500 µL on half-face, five days a week during 6 weeks
Intervention Type
Drug
Intervention Name(s)
CD0271/CD1579 gel
Intervention Description
500 µL on half-face, five days a week during 6 weeks
Intervention Type
Drug
Intervention Name(s)
CD0271/CD1579 gel placebo
Intervention Description
500 µL on half-face, five days a week during 6 weeks
Primary Outcome Measure Information:
Title
Inflammatory Lesion Count (Papules and Pustules) at Day 40
Description
Inflammatory lesion count corresponded to the sum of papules and pustules.
Time Frame
Day 40
Secondary Outcome Measure Information:
Title
Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)
Description
Inflammatory lesion count corresponded to the sum of papules and pustules.
Time Frame
Baseline (Day 1)
Title
Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40
Description
Inflammatory lesion count corresponded to the sum of papules and pustules.
Time Frame
Baseline (Day 1), and Day 40
Title
Total Lesion Count at Baseline (Day 1) and Day 40
Description
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.
Time Frame
Baseline (Day 1), and Day 40
Title
Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40
Description
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.
Time Frame
Baseline (Day 1), and Day 40
Title
Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40
Description
Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.
Time Frame
Baseline (Day 1), and Day 40
Title
Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40
Description
Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.
Time Frame
Baseline (Day 1), and Day 40
Title
Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40
Description
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.
Time Frame
Day 40
Title
Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40
Description
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.
Time Frame
Day 40
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
From start of study up to follow up (Week 7)
Title
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)
Description
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.
Time Frame
From Day 1 up Follow up (Week 7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Galderma Investigational Site (# 8060)
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Galderma Investigational site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Galderma investigational site
City
Nantes
Country
France
Facility Name
Galderma investigational site
City
Nice
Country
France
Facility Name
Galderma investigational site
City
Berlin
Country
Germany
Facility Name
Galderma investigational site
City
Bochum
Country
Germany
Facility Name
Galderma investigational site
City
Munster
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of CD5024 1% in Acne Vulgaris
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