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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02849860

Enrollment

Registered

2016-07-29

Start date

2014-02-28

Completion date

2016-10-31

Last updated

2017-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

Brief 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.

Detailed 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.

Interventions

DRUGIDP-121 Lotion

Lotion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

9 Years to 17 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluators Global Severity Score at Day 15	15 Days	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026