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

Use our guide to learn which trials are right for you!

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
2
sites
Austin, Texas 78759
1065
mi
from 43215
Austin, TX
Click here to add this to my saved trials
College Station, Texas 77845
987
mi
from 43215
College Station, TX
Click here to add this to my saved trials