Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

NCT02850003 | Completed Phase 1

• 1 other identifier: V01-120A-501
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IDP-120 Gel

EXPERIMENTAL

Gel

Drug: IDP-120 Gel

Interventions

IDP-120 Gel DRUG

Gel

Also known as: Gel

IDP-120 Gel

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Valeant Site 01

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Anya Loncaric

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 29, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)