Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison With Tazorac Cream

NCT02849873 | Completed Phase 1 FDA Drug

• 1 other identifier: V01-123A-501
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison with Tazorac Cream.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Evaluator's Global Severity Score: At Day 15 (or ET), 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

Study Arms (2)

IDp-123 Lotion

EXPERIMENTAL

Lotion

Drug: IDP-123 Lotion

Tazorac Cream

ACTIVE COMPARATOR

Cream

Drug: Tazorac Cream

Interventions

IDP-123 Lotion DRUG

Lotion

Also known as: IDP-123

IDp-123 Lotion

Tazorac Cream DRUG

Cream

Also known as: Tazorac

Tazorac Cream

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, at least 9 years of age (at least 12 years of age for Tazorac Cream).
• Verbal and written informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if the subject reaches age of consent during the study they should be re-consented at the next study visit).
• Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit.
• Subjects with facial acne inflammatory lesion 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.

You may not qualify if:

• Use of an investigational drug or device within 30 days of enrollment 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, dermatitis, eczema.
• 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 count 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

Birmingham, Alabama, 35201, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

tazarotene

Condition Hierarchy (Ancestors)

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

Study Officials

• Anya Loncaric

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)