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CompletedNCT02849873Updated Jul 19, 2018

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

A Phase 1 interventional study of IDP-123 Lotion and Tazorac Cream in Acne, sponsored by Bausch Health Americas, Inc.. Completed at 1 site in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2018-07-19.

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

From the registry’s dates

  • Primary completion was Dec 2016, 9 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
9 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Randomized study evaluating the absorption and systematic pharmacokinetics of IDP-123 lotion in comparison with Tazorac Cream in subjects with moderate to severe acne vulgaris under maximal use conditions.

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 and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    IDp-123 Lotion

    Lotion

    Drug: IDP-123 Lotion

  • Active comparator
    Tazorac Cream

    Cream

    Drug: Tazorac Cream

Interventions

  • DrugIDP-123 Lotion

    Lotion

    Also known as: IDP-123

  • DrugTazorac Cream

    Cream

    Also known as: Tazorac

06

What researchers measure

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)

    Time frame: 15 Days

07

Study locations

1 site
  • Valeant Site 01
    Birmingham, Alabama 35201, United States
08

References and documents

Individual participant data

Plan to share: Yes

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 Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02849873
Lead sponsor
Bausch Health Americas, Inc.
Responsible party
Sponsor
First posted
Jul 29, 2016
Start date
Jun 2016
Primary completion
Dec 2016
Completion
Jan 2017
Last update
Jul 19, 2018

Study contacts

Anya Loncaric
study director · Valeant Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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