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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849860
• Other study ID #: V01-121A-501
• 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
• 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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

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