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
1 other identifier
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2014
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 6, 2016
CompletedFirst Posted
Study publicly available on registry
July 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedDecember 14, 2017
December 1, 2017
2.6 years
July 6, 2016
December 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluators Global Severity Score at Day 15
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 (1)
IDP-121 Lotion
EXPERIMENTALLotion
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Valeant Site 02
Austin, Texas, 78759, United States
Valeant Site 01
College Station, Texas, 77845, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anya Loncaric
Valeant Pharmaceutical
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
February 1, 2014
Primary Completion
September 1, 2016
Study Completion
October 1, 2016
Last Updated
December 14, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share