A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

  • STATUS
    Recruiting
Updated on 7 November 2020

Summary

Clinical research study for the treatment of moderate to severe acne vulgaris.

Description

The main purpose of this study is to evaluate the safety, efficacy, and tolerability of a once-daily topical application of IDP-126 Gel in subjects with moderate to severe acne. Subjects must be at least 9 years of age or older and generally healthy. IDP-126 Gel is a fixed dose combination of clindamycin phosphate, benzoyl peroxide (BPO), and adapalene. This study will compare IDP-126 Gel to its active gel components (clindamycin phosphate, BPO, adapalene), as well as its Vehicle Gel. “Vehicle” is a term to describe a gel that looks like the IDP-126 Gel but does not contain any active drug (similar to a placebo). If you decide to be in this research study, you may receive either the IDP-126 Gel, a combination of the individual components of the IDP-126 Gel (clindamycin phosphate, BPO, and/or adapalene), or the IDP-126 Vehicle Gel.

Participation will be approximately 12 weeks (3 months), including 6 in office visits:

You may receive up to $300.00 if you complete the whole study, as a compensation for your time and travel.

Details
Condition Family Practice, Dermatology, Acne Vulgaris, Healthy People 2010
Clinical Study IdentifierTX154547
Last Modified on7 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Moderate to severe facial acne
-100 inflammatory lesions
-150 non-inflammatory lesions (blackheads/whiteheads)
or fewer facial nodules
Agreement to use products and makeup that is approved by research coordinator
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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