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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.
Study drugs application will be performed once daily, 5 days a week during 6 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD5024 1% cream | Experimental | Active drug; |
|
| CD5024 cream placebo | Placebo Comparator | Placebo of active drug; |
|
| CD0271/CD1579 gel | Other | Positive control; |
|
| CD0271/CD1579 gel placebo | Other | Placebo of positive control; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD5024 1% cream | Drug | 500 µL on half-face, five days a week during 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Lesion Count (Papules and Pustules) at Day 40 | Inflammatory lesion count corresponded to the sum of papules and pustules. | Day 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1) | Inflammatory lesion count corresponded to the sum of papules and pustules. | Baseline (Day 1) |
| Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site (# 8060) | Windsor | Ontario | N8W 5L7 | Canada | ||
| Galderma Investigational site |
A total of 70 participants were randomized, of which 64 participants completed the study.
This study was conducted at six centers in three countries (Germany, France, Canada) between 25 April 2016 (first participant screened) to 02 November 2016 (last participant completed).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I: CD5024 Cream Versus Its Vehicle | Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications. |
| FG001 | Group II: Epiduo Gel Versus Its Vehicle | Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I: CD5024 Cream Versus Its Vehicle | Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inflammatory Lesion Count (Papules and Pustules) at Day 40 | Inflammatory lesion count corresponded to the sum of papules and pustules. | This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT-population included all participants who were randomized. Outcome measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face. | Posted | Mean | Standard Deviation | lesion count | Day 40 | One side of face | One side of face |
|
From start of study up to follow up (Week 7)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I: CD5024 Cream Versus Its Vehicle | Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | +1 | Clinical.Studies@galderma.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| 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 |
|
Inflammatory lesion count corresponded to the sum of papules and pustules.
| Baseline (Day 1), and Day 40 |
| 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. | Baseline (Day 1), and Day 40 |
| 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. | Baseline (Day 1), and Day 40 |
| Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Non-inflammatory lesion counts corresponded to the sum of open and closed comedones. | Baseline (Day 1), and Day 40 |
| Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40 | Non-inflammatory lesion counts corresponded to the sum of open and closed comedones. | Baseline (Day 1), and Day 40 |
| 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. | Day 40 |
| 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. | Day 40 |
| 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. | From start of study up to follow up (Week 7) |
| 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. | From Day 1 up Follow up (Week 7) |
| Montreal |
| Quebec |
| Canada |
| Galderma investigational site | Nantes | France |
| Galderma investigational site | Nice | France |
| Galderma investigational site | Berlin | Germany |
| Galderma investigational site | Bochum | Germany |
| Galderma investigational site | Münster | Germany |
| Personal Reasons |
|
| Group II: Epiduo Gel Versus Its Vehicle |
Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of inflammatory lesions | Mean | Standard Deviation | Lesion Count |
|
| CD5024 1% Cream Matched Placebo |
Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6. |
| OG002 | Adapalene Benzoyl Peroxyde | Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6. |
| OG003 | Adapalene Benzoyl Peroxyde Matched Placebo | Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6. |
|
|
|
| Secondary | Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1) | Inflammatory lesion count corresponded to the sum of papules and pustules. | This analysis was performed on ITT population. ITT population included all partcipants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face. | Posted | Mean | Standard Deviation | lesion count | Baseline (Day 1) | One side of face | One side of face |
|
|
|
| Secondary | Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40 | Inflammatory lesion count corresponded to the sum of papules and pustules. | This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face. | Posted | Mean | Standard Deviation | percent reduction of lesion count | Baseline (Day 1), and Day 40 | One side of face | One side of face |
|
|
|
| Secondary | 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. | This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT population included all participants who were randomized. Outcome Measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face. | Posted | Mean | Standard Deviation | lesion count | Baseline (Day 1), and Day 40 | One side of face | One side of face |
|
|
|
| Secondary | 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. | This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face. | Posted | Mean | Standard Deviation | percent reduction in total lesion count | Baseline (Day 1), and Day 40 | One side of face | One side of face |
|
|
|
| Secondary | Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Non-inflammatory lesion counts corresponded to the sum of open and closed comedones. | This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face. | Posted | Mean | Standard Error | lesion count | Baseline (Day 1), and Day 40 | One side of face | One side of face |
|
|
|
| Secondary | Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40 | Non-inflammatory lesion counts corresponded to the sum of open and closed comedones. | This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face. | Posted | Mean | Standard Deviation | percent reduction of lesion count | Baseline (Day 1), and Day 40 | One side of face | One side of face |
|
|
|
| Secondary | 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. | This analysis was performed on ITT population. ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Day 40 |
|
|
|
| Secondary | 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. | This analysis was performed on ITT population. ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this endpoint. | Posted | Count of Participants | Participants | Day 40 |
|
|
|
| Secondary | 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. | This analysis was performed on safety population. Safety population included participants in the ITT population who received at least 1 application of the investigational product. Number of participants with AE's were reported. | Posted | Count of Participants | Participants | From start of study up to follow up (Week 7) |
|
|
|
| Secondary | 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. | Safety population included participants in the ITT population who received at least 1 application of the investigational product. Here 'n' (number analyzed) signifies number of participants who were evaluable for each specified category. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face. | Posted | Count of Participants | Participants | From Day 1 up Follow up (Week 7) |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 32 |
| 48 |
| EG001 | Group II: Epiduo Gel Versus Its Vehicle | Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications. | 0 | 22 | 0 | 22 | 11 | 22 |
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
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| One side of face |
|
| One side of face |
|
| One side of face |
|
| Day 40 |
|
| One side of face |
|
| One side of face |
|
| Day 40 |
|
| One side of face |
|
| Day 40 (No clinical difference between Active and Vehicle) |
|
| Day 40 (Vehicle better than Active) |
|
| Day 40 (Vehicle much better than Active) |
|
| Day 40 (No clinical difference between Active and Vehicle) |
|
| Day 40 (Vehicle better than Active) |
|
| Day 40 (Vehicle much better than Active) |
|
|
| Face: Erythema: 1-Mild |
|
|
| Face: Erythema: 2-Moderate |
|
|
| Face: Scaling/Desquamation: 0-None |
|
|
| Face: Scaling/Desquamation: 1-Mild |
|
|
| Face: Scaling/Desquamation: 2- Moderate |
|
|
| Face: Dryness: 0-None |
|
|
| Face: Dryness: 1-Mild |
|
|
| Face: Dryness: 2-Moderate |
|
|
| Face: Stinging/Burning: 0-None |
|
|
| Face: Stinging/Burning: 1-Mild |
|
|
| Face: Stinging/Burning: 2-Moderate |
|
|
| Ear: Erythema: 0-None |
|
|
| Ear: Erythema: 1-Mild |
|
|
| Ear: Erythema: 2-Moderate |
|
|
| Ear: Scaling/Desquamation: 0-None |
|
|
| Ear: Scaling/Desquamation: 1-Mild |
|
|
| Ear: Scaling/Desquamation: 2-Moderate |
|
|
| Ear: Dryness: 0-None |
|
|
| Ear: Dryness: 1-Mild |
|
|
| Ear: Dryness: 2-Moderate |
|
|
| Ear: Stinging/Burning: 0-None |
|
|
| Ear: Stinging/Burning: 1-Mild |
|
|
| Ear: Stinging/Burning: 2-Moderate |
|
|