Approval Probability
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lidamycin and benzoyl peroxide 1.2%/3.75% combination · 1 trial · 1 indication
Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy
| Arm | Type | Description |
|---|---|---|
| lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combo | EXPERIMENTAL | lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days |
| Name | Type | Description |
|---|---|---|
| lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination | DRUG | At Day 15, patients will be re-assessed and dispensed the investigational product and instructed on its daily use. Patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study). |
Inclusion Criteria: * Women 18 years or older * Women who have had their first menses at least 12 months ago, and who currently have regular menses. * Subjects must be able to read and understand English, and be able and willing to complete the survey. * Subjects must have a self-reported complaint...
Lidamycin and benzoyl peroxide 1.2%/3.75% combination is an investigational small molecule dermatology therapy being developed by Bausch Health Companies Inc. for actinic keratosis. It combines lidamycin phosphate with benzoyl peroxide in a fixed-dose topical formulation. It is in Phase 2 clinical development and has not been approved by the FDA.
Lidamycin and benzoyl peroxide 1.2%/3.75% combination is being studied for the treatment of actinic keratosis, a dermatologic condition. The clinical program has evaluated it in adult female participants aged 18 years and older in the United States. It remains investigational and is not approved for any indication.
Bausch Health Companies Inc., which trades under the ticker BHC, is the developer of lidamycin and benzoyl peroxide 1.2%/3.75% combination. The company is advancing the fixed-dose topical combination through clinical development for actinic keratosis.
Lidamycin and benzoyl peroxide 1.2%/3.75% combination is in Phase 2 clinical development. It is an investigational product and has not received FDA approval. One Phase 2 trial has been completed, and no trials are currently active.
Lidamycin and benzoyl peroxide 1.2%/3.75% combination has been evaluated in one completed Phase 2 trial, NCT03122457, titled Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide. That study enrolled 22 participants in the United States, was open to females aged 18 years and older, and was uncontrolled, without randomization or blinding.