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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02850003
Other study ID # V01-120A-501
Secondary ID
Status Completed
Phase Phase 1
First received July 6, 2016
Last updated September 20, 2017
Start date June 2016
Est. completion date November 2016

Study information

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

Clinical Trial Summary

Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.


Description:

An Open-label study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2016
Est. primary completion date October 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 (16 years 11 months)

- Written and verbal 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) or 4 (severe) on the Evaluator's Global Severity assessment.

- Subject with facial acne inflammatory lesion count no less than 20 but no more than 40.

- Subject with facial acne non-inflammatory lesion count no less than 20 but no more than 100.

Key Exclusion Criteria:

- Use of an investigational drug or device within 30 days of enrollment, previous participation in a research study with IDP-120 Gel, or participation in a research study concurrent with this study.

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

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

- Subjects with a facial beard or mustache that could interfere with the study assessments

- Subjects with more than 2 facial nodules.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IDP-120 Gel
Gel

Locations

Country Name City State
United States Valeant Site 01 Austin 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 the 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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