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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02849860
Other study ID # V01-121A-501
Secondary ID
Status Completed
Phase Phase 1
First received July 6, 2016
Last updated December 12, 2017
Start date February 2014
Est. completion date October 2016

Study information

Verified date December 2017
Source Valeant Pharmaceuticals International, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 9 Years to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IDP-121 Lotion
Lotion

Locations

Country Name City State
United States Valeant Site 02 Austin Texas
United States Valeant Site 01 College Station Texas

Sponsors (1)

Lead Sponsor Collaborator
Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluators Global Severity Score at Day 15 Acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe). 15 Days
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