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CompletedNCT02850003Updated Sep 25, 2017

Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

A Phase 1 interventional study of IDP-120 Gel in Acne, sponsored by Bausch Health Americas, Inc.. Completed at 1 site in United States. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by Bausch Health Americas, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
9 Years to 17 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Acne
03

In context

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    IDP-120 Gel

    Gel

    Drug: IDP-120 Gel

Interventions

  • DrugIDP-120 Gel

    Gel

    Also known as: Gel

06

What researchers measure

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).

    Time frame: 15 Days

07

Study locations

1 site
  • Valeant Site 01
    Austin, Texas 78759, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02850003
Lead sponsor
Bausch Health Americas, Inc.
Responsible party
Sponsor
First posted
Jul 29, 2016
Start date
Jun 2016
Primary completion
Oct 2016
Completion
Nov 2016
Last update
Sep 25, 2017

Study contacts

Anya Loncaric
study director · Valeant Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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