Phase 2
N=431
A Study of a New Drug Treatment for Acne
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT01326780 ↗Enrolled (actual)
431
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Change in Total Acne Lesion Counts — -26.0; -25.2; -29.4; -33.1 Lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 1.2% JNJ 10229570-AAA (Drug); 2.4% JNJ 10229570-AAA (Drug); 3.6% JNJ 10229570-AAA (Drug); Vehicle control (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Acne Lesion Counts |
-26.0; -25.2; -29.4; -33.1 | — |
| SECONDARY Change From Baseline in the Non-inflammatory Acne Lesion Counts |
-12.6; -12.0; -14.3; -15.3 | — |
| SECONDARY Change From Baseline in the Inflammatory Acne Lesion Counts |
-13.4; -13.2; -15.1; -18.1 | — |
| SECONDARY Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts |
-28.6; -21.7; -31.2; -30.8 | — |
| SECONDARY Percent Change From Baseline in the Inflammatory Acne Lesion Counts |
-39.6; -35.4; -44.7; -48.5 | — |
| SECONDARY Percent Change From Baseline in Total Acne Lesion Counts |
-33.9; -27.8; -36.5; -37.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01326780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.