Absorption and Systematic Pharmacokinetics of IDP-121 Lotion in Subjects With Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - 17
Updated:12/16/2017
Start Date:February 2014
End Date:October 2016

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A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-121 Lotion in Subjects With Acne Vulgaris Under Maximal Use Conditions

Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant
metabolites after topical dermal application of IDP-121 lotion.

Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant
metabolites after topical dermal application of IDP-121 lotion in subjects with moderate to
severe acne vulgaris under maximal use conditions.

Key Inclusion Criteria:

- Male or female, between the ages of 9 and <17 years (16 years 11 months inclusive).

- Written and oral informed consent must be obtained. Subjects less than age of consent
must sign an assent for the study and a parent or legal guardian must sign the
informed consent.

- Subject must have a score of 3 (moderate) to 4 (severe) on the Evaluator's Global
Severity Assessment at the screening and baseline visit in the facial area.

- Subjects with facial acne inflammatory lesions count no less than 20 but no more than
40.

- Subjects with facial acne non-inflammatory lesions count no less than 20 but no more
than 100.

Key Exclusion Criteria:

- Use of investigational drug or device within 30 days of enrollment or participation in
research study or concurrent study with this study.

- Any dermatological conditions on the face that could interfere with clinical
evaluations acne conglobate, acne fulminans, secondary acne, perioral dermatitis,
clinical significant rosacea, gram negative folliculitis.

- Any underlying disease(s) or some other dermatological condition of the face that
requires the use of interfering topical or systemic therapy or makes evaluations and
lesion count inconclusive.

- Subjects with facial beard or mustache that could interfere with any study
assessments.
We found this trial at
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College Station, Texas 77845
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Austin, Texas 78759
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Austin, TX
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