Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

Acne Clinical Trial

Official title:

A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850003
• Other study ID #: V01-120A-501
• 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
• 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.

Related Conditions & MeSH terms

• Acne

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