Phase 3
Completed N=1,315
Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
Source: ClinicalTrials.gov NCT00776919 ↗Enrolled (actual)
1,315
Serious AEs
0.1%
Results posted
Jan 2012
Primary outcomePrimary: Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 — 129; 82; 100; 59 participants — p=<0.001
Summary
This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 |
129; 82; 100; 59 | <0.001 sig |
| PRIMARY Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts |
-18.2; -15.6; -16.8; -13.1 | <0.001 sig |
| PRIMARY Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts |
-24.8; -19.8; -22.2; -14.8 | <0.001 sig |
| PRIMARY Mean Change From Baseline to Week 12 in Total Lesion Counts |
-43.0; -35.5; -39.0; -27.8 | <0.001 sig |
| SECONDARY Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) |
-68.9; -58.1; -61.8; -48.8; -53.9; -43.3 | — |
| SECONDARY Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 |
209; 171; 189; 154 | — |
| SECONDARY Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 |
148; 91; 116; 81 | — |
| SECONDARY Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Mean Change From Baseline to Week 12 in Temperature |
-0.1; 0.0; 0.0; 0.0 | — |
| SECONDARY Mean Change From Baseline to Week 12 in Pulse Rate |
1; 2; 2; 2 | — |
| SECONDARY Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling |
-0.05; -0.01; -0.07; -0.02; -0.07; -0.07 | — |
| SECONDARY Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging |
-0.11; -0.18; -0.04; -0.06; -0.11; -0.18 | — |
| SECONDARY Mean Duration of Study Product Use |
79.5; 78.0; 78.0; 77.8 | — |
| SECONDARY Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation |
1; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Be 12 to 45 years of age, inclusive, and in good general health.
- Clinical diagnosis of acne vulgaris
- Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
- Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.
Exclusion Criteria
- Are pregnant or breast-feeding.
- Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes.
- Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks.
- Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
- Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks.
- Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
- Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks.
- Used abradents or facial procedures, within the past 2 weeks.
- Use medications that may exacerbate acne.
- Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product.
- Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.
Data sourced from ClinicalTrials.gov (NCT00776919). 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. Informational only — not medical advice.