Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne vulgaris.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris

NCT02938494

Acne Vulgaris

COMPLETED PHASE2

A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

NCT02537483

Acne Vulgaris

UNKNOWN PHASE2

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

NCT02849873

Acne

COMPLETED PHASE1

A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® Cream, 0.1% in the Topical Treatment of Acne Vulgaris

NCT03341910

Acne Vulgaris

COMPLETED PHASE2

A Study Comparing Tazarotene Cream 0.1% to Tazorac® and Both to a Placebo Control in the Treatment of Acne Vulgaris

NCT02411955

Acne Vulgaris

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-123 Lotion in comparison with Tazorac Cream, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne. Treatment success will be evaluated by changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Score. IDP-123 is a lotion for the topical treatment of acne.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IDP-123 Lotion

IDP-123 Lotion, applied topically to the face, once daily for 12 weeks.

Group Type EXPERIMENTAL

IDP-123 Lotion

Intervention Type DRUG

Investigational Product: IDP-123 Lotion

Tazorac Cream, 0.1%

Tazorac Cream (tazarotene 0.1%), applied topically to the face, once daily for 12 weeks.

Group Type ACTIVE_COMPARATOR

Tazorac Cream, 0.1%,

Intervention Type DRUG

Comparator Product: Tazorac Cream, 0.1%

Vehicle Cream

Vehicle Cream, applied topically to the face, once daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type DRUG

Comparator Product: Vehicle Cream

Vehicle Lotion

Vehicle Lotion, applied topically to the face, once daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Vehicle Lotion

Intervention Type DRUG

Comparator Product: Vehicle Lotion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IDP-123 Lotion

Investigational Product: IDP-123 Lotion

Intervention Type DRUG

Tazorac Cream, 0.1%,

Comparator Product: Tazorac Cream, 0.1%

Intervention Type DRUG

Vehicle Cream

Comparator Product: Vehicle Cream

Intervention Type DRUG

Vehicle Lotion

Comparator Product: Vehicle Lotion

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

tazarotene

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female at least 12 years of age and older
* Written and verbal informed consent must be obtained
* Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment
* Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits
* Subjects must be willing to comply with study instructions and return to the clinic for required visits

Exclusion Criteria

* Any dermatological conditions on the face that could interfere with clinical evaluations
* 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 a facial beard or mustache that could interfere with the study assessments
* Subjects who are unable to communicate or cooperate with the Investigator
* Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in the study

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No