Acne Vulgaris
Conditions
Keywords
Acne, Irritation, Safety, Sebum
Brief summary
A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.
Detailed description
Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.
Interventions
DRUG1.2% JNJ 10229570-AAA
1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
DRUG2.4% JNJ 10229570-AAA
2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
DRUG3.6% JNJ 10229570-AAA
3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
OTHERVehicle control
Color matched cream vehicle, applied once daily to the face for 12 weeks
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 12 years of age or older, with moderate facial acne vulgaris as defined in the protocol * If female of childbearing potential, must take a pregnancy test and have a negative result * Females of childbearing potential must also agree to use an adequate method of birth control, which would include: * systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study) * Condom with spermicide * IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods
Exclusion criteria
* Known sensitivity to any of the ingredients in the study medication * More than 3 nodulocystic acne lesions * Use of acne treatments, therapies or medications within protocol-specified timeframes * Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety * Excessive facial hair that may interfere with application of the medication and/or evaluations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Acne Lesion Counts | Baseline to Week 12 | Change in lesion counts between baseline and end of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Non-inflammatory Acne Lesion Counts | Baseline through Week 12 | Change in sum of open and closed comedones. |
| Change From Baseline in the Inflammatory Acne Lesion Counts | Baseline through Week 12 | Change in sum of papules and pustules |
| Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts | Baseline through Week 12 | Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones) |
| Percent Change From Baseline in the Inflammatory Acne Lesion Counts | Baseline through Week 12 | Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules) |
| Percent Change From Baseline in Total Acne Lesion Counts | Baseline through Week 12. | Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions) |
Countries
United States
Participant flow
Recruitment details
18 investigational sites: First patient enrolled: 08 March 2011, Last patient completed: 02 March 2012
Pre-assignment details
male and female subjects with moderate facial acne vulgaris, who met the entry criteria, were randomized with equal allocation to either 1.2%, 2.4%, or 3.6% JNJ 10229570-AAA cream or color-matched vehicle
Participants by arm
| Arm | Count |
|---|---|
| 0% Facial Cream Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks | 106 |
| 1.2% Facial Cream 1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks | 109 |
| 2.4% Facial Cream 2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks | 109 |
| 3.6% Facial Cream 3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks | 107 |
| Total | 431 |
Baseline characteristics
| Characteristic | 2.4% Facial Cream | 3.6% Facial Cream | Total | 0% Facial Cream | 1.2% Facial Cream |
|---|---|---|---|---|---|
| Age, Continuous | 19.7 years STANDARD_DEVIATION 7 | 17.9 years STANDARD_DEVIATION 5.5 | 18.7 years STANDARD_DEVIATION 6.2 | 19.9 years STANDARD_DEVIATION 7.6 | 17.3 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 109 Participants | 107 Participants | 431 Participants | 106 Participants | 109 Participants |
| Sex: Female, Male Female | 51 Participants | 53 Participants | 198 Participants | 49 Participants | 45 Participants |
| Sex: Female, Male Male | 58 Participants | 54 Participants | 233 Participants | 57 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 106 | 17 / 109 | 14 / 109 | 15 / 107 |
| serious Total, serious adverse events | 0 / 106 | 0 / 109 | 0 / 109 | 0 / 107 |
Outcome results
Primary
Change in Total Acne Lesion Counts
Change in lesion counts between baseline and end of study
Time frame: Baseline to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0% Facial Cream | Change in Total Acne Lesion Counts | -26.0 Lesions | Standard Deviation 27.43 |
| 1.2% Facial Cream | Change in Total Acne Lesion Counts | -25.2 Lesions | Standard Deviation 30.23 |
| 2.4% Facial Cream | Change in Total Acne Lesion Counts | -29.4 Lesions | Standard Deviation 30.3 |
| 3.6% Facial Cream | Change in Total Acne Lesion Counts | -33.1 Lesions | Standard Deviation 29.32 |
Secondary
Change From Baseline in the Inflammatory Acne Lesion Counts
Change in sum of papules and pustules
Time frame: Baseline through Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0% Facial Cream | Change From Baseline in the Inflammatory Acne Lesion Counts | -13.4 Lesions | Standard Deviation 13.4 |
| 1.2% Facial Cream | Change From Baseline in the Inflammatory Acne Lesion Counts | -13.2 Lesions | Standard Deviation 16.3 |
| 2.4% Facial Cream | Change From Baseline in the Inflammatory Acne Lesion Counts | -15.1 Lesions | Standard Deviation 14.1 |
| 3.6% Facial Cream | Change From Baseline in the Inflammatory Acne Lesion Counts | -18.1 Lesions | Standard Deviation 12.9 |
Secondary
Change From Baseline in the Non-inflammatory Acne Lesion Counts
Change in sum of open and closed comedones.
Time frame: Baseline through Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0% Facial Cream | Change From Baseline in the Non-inflammatory Acne Lesion Counts | -12.6 Lesions | Standard Deviation 20.3 |
| 1.2% Facial Cream | Change From Baseline in the Non-inflammatory Acne Lesion Counts | -12.0 Lesions | Standard Deviation 21.2 |
| 2.4% Facial Cream | Change From Baseline in the Non-inflammatory Acne Lesion Counts | -14.3 Lesions | Standard Deviation 20.9 |
| 3.6% Facial Cream | Change From Baseline in the Non-inflammatory Acne Lesion Counts | -15.3 Lesions | Standard Deviation 21.9 |
Secondary
Percent Change From Baseline in the Inflammatory Acne Lesion Counts
Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)
Time frame: Baseline through Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0% Facial Cream | Percent Change From Baseline in the Inflammatory Acne Lesion Counts | -39.6 Percent change | Standard Deviation 36.3 |
| 1.2% Facial Cream | Percent Change From Baseline in the Inflammatory Acne Lesion Counts | -35.4 Percent change | Standard Deviation 45.3 |
| 2.4% Facial Cream | Percent Change From Baseline in the Inflammatory Acne Lesion Counts | -44.7 Percent change | Standard Deviation 41.1 |
| 3.6% Facial Cream | Percent Change From Baseline in the Inflammatory Acne Lesion Counts | -48.5 Percent change | Standard Deviation 31.9 |
Secondary
Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts
Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones)
Time frame: Baseline through Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0% Facial Cream | Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts | -28.6 Percent change | Standard Deviation 39.3 |
| 1.2% Facial Cream | Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts | -21.7 Percent change | Standard Deviation 43.1 |
| 2.4% Facial Cream | Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts | -31.2 Percent change | Standard Deviation 41 |
| 3.6% Facial Cream | Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts | -30.8 Percent change | Standard Deviation 37.6 |
Secondary
Percent Change From Baseline in Total Acne Lesion Counts
Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)
Time frame: Baseline through Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0% Facial Cream | Percent Change From Baseline in Total Acne Lesion Counts | -33.9 Percent change | Standard Deviation 32.7 |
| 1.2% Facial Cream | Percent Change From Baseline in Total Acne Lesion Counts | -27.8 Percent change | Standard Deviation 35.1 |
| 2.4% Facial Cream | Percent Change From Baseline in Total Acne Lesion Counts | -36.5 Percent change | Standard Deviation 36.5 |
| 3.6% Facial Cream | Percent Change From Baseline in Total Acne Lesion Counts | -37.7 Percent change | Standard Deviation 29.9 |