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Also known as Benzoyl peroxide gel, Benzoyl peroxide
Benzoyl peroxide 3% · 1 trial · 1 indication
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts \[only post-Baseline\]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Benzoyl peroxide/clindamycin gel + tazarotene cream |
| 2 | ACTIVE_COMPARATOR | Benzoyl peroxide/clindamycin gel + vehicle cream |
| 3 | ACTIVE_COMPARATOR | Benzoyl peroxide gel + tazarotene cream |
| 4 | ACTIVE_COMPARATOR | Clindamycin gel + tazarotene cream |
| 5 | ACTIVE_COMPARATOR | Vehicle gel+ tazarotene cream |
| 6 | PLACEBO_COMPARATOR | Vehicle gel + vehicle cream |
| Name | Type | Description |
|---|---|---|
| Benzoyl peroxide gel | DRUG | 5% benzoyl peroxide in a gel applied topically once a day |
| Clindamycin gel | DRUG | 1% clindamycin phosphate applied topically once a day |
| Tazarotene cream | DRUG | 0.1 % tazarotene in a cream applied topically once a day |
| Vehicle gel | DRUG | Vehicle gel is an identical gel without the active ingredients |
| Vehicle cream | DRUG | Vehicle cream is an identical cream without the active ingredients |
Inclusion Criteria: * Inclusion Criteria: Subjects must be males or females 12 to 45 years of age. * Subjects must have acne on their face. * Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be pr...
Benzoyl peroxide 3% is being studied for the treatment of acne vulgaris, a common skin condition. It is a small molecule therapy in Phase 2 clinical development. It is not currently approved for marketing, and it is being investigated as part of a combination cream that also includes clindamycin and tazarotene.
GSK plc, which trades under the ticker GSK, is the developer of benzoyl peroxide 3% for acne vulgaris. The company sponsored the Phase 2 clinical trial evaluating the therapy in combination with clindamycin and tazarotene in subjects with acne.
Benzoyl peroxide 3% is in Phase 2 clinical development for acne vulgaris. It is an investigational therapy and has not been approved by the FDA. The Phase 2 trial evaluating it has been completed, and no active trials are currently listed for this asset.
Benzoyl peroxide 3% was evaluated in the Phase 2 trial NCT00713609, titled Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne. The trial enrolled 591 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States. It has been completed.
Yes. Benzoyl peroxide 3% is also known as benzoyl peroxide gel, or simply benzoyl peroxide. These names refer to the same small molecule therapy being developed by GSK for acne vulgaris. The 3% designation refers to the concentration of benzoyl peroxide in the formulation.
The Phase 2 trial of benzoyl peroxide 3% in combination with clindamycin and tazarotene, NCT00713609, enrolled 591 participants with acne vulgaris. The study included participants aged 12 years and older of all sexes and was conducted in the United States. It was randomized, double-blind, and placebo-controlled.