A Phase 1 interventional study of Clindamycin Phosphate and Clindamycin Phosphate RLD in Acne Vulgaris, sponsored by Taro Pharmaceuticals USA. Completed at 1 site in United States. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Taro Pharmaceuticals USA (part of Sun Pharmaceutical Industries Limited) · Phase 1, Interventional, and Treatment
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 550 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
First submitted after Taro Pharmaceuticals USA became part of Sun Pharmaceutical Industries Limited.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical, once daily, for 84 days.
Drug: Clindamycin Phosphate
Topical, once daily, for 84 days
Drug: Clindamycin Phosphate RLD
Topical, once daily, for 84 days
Drug: Placebos
A thin film of investigation product will be applied to the affected areas of the face once daily
Also known as: Lotion
A thin film of investigation product will be applied to the affected areas of the face once daily
Also known as: Lotion
A thin film of investigation product will be applied to the affected areas of the face once daily
Also known as: Vehicle
Demonstration of Bioequivalence
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
Time frame: Week 12
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clindamycin phosphate