Approval Probability
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Benzoyl peroxide · 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 is used for the treatment of Acne Vulgaris. It is a small molecule being developed by GSK plc for dermatological use. The drug is currently in Phase 2 clinical development, meaning it is investigational and has not yet been approved for commercial use.
Benzoyl peroxide is a small molecule with a mechanism of action that involves its oxidizing properties. It is being studied for its efficacy in treating Acne Vulgaris, a common skin condition. The specific molecular target has not been disclosed in the available clinical trial information.
Benzoyl peroxide is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of Acne Vulgaris.
Benzoyl peroxide is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The drug is being studied for its potential use in treating Acne Vulgaris, and its safety and efficacy are still being evaluated in clinical trials.
Benzoyl peroxide has been studied in one completed clinical trial, identified as NCT00713609. This Phase 2 trial, titled 'Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne,' enrolled 591 participants with Acne Vulgaris in the United States. The trial was randomized, double-blind, and placebo-controlled.
Benzoyl peroxide is a component of the combination product Clindamycin/Benzoyl Peroxide/Tazarotene cream, which was evaluated in clinical trial NCT00713609. The trial studied the safety and efficacy of this combination in subjects with Acne Vulgaris. Benzoyl peroxide itself is an active ingredient in this combination therapy.