MedDataX Logo

Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris

NCT ID: NCT03915860

Last Updated: 2021-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-27

Study Completion Date

2019-12-23

Brief Summary

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

Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with Moderate Facial and Truncal Acne Vulgaris

Detailed Description

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

There was no formal hypothesis to be tested. Approximately 50 subjects would be enrolled to evaluate the subject reported outcomes (quality of life and satisfaction survey). The sample size was not based on any formal hypothesis testing.

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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Trifarotene

Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.

Group Type EXPERIMENTAL

Trifarotene

Intervention Type DRUG

Topical Cream

Interventions

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

Trifarotene

Topical Cream

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* The participant was a male or female, 9 years of age or older, at Screening visit.
* The participant had moderate acne at Screening and Baseline.
* The participant was a female of non childbearing potential.
* The participant was a female of childbearing potential with a negative pregnancy test and who was strictly abstinent or who agreed to use an effective and approved contraceptive method for the duration of the study and at least 1 months after the last study drug application.

Exclusion Criteria

* The participant had severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g., chloracne, drug induced acne, etc.).
* The participant had any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant took part to the trial.
* The participant had been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the participant was planning intense UV exposure during the study (i.ed, occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.).
* The participant was unwilling to refrain from use of prohibited medication during the Clinical Trial.
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Galderma Investigational Site

Fort Smith, Arkansas, United States

Site Status

Galderma Investigational Site

Beverly, Massachusetts, United States

Site Status

Galderma Investigational Site

Portsmouth, New Hampshire, United States

Site Status

Galderma Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Galderma Investigational Site

Austin, Texas, United States

Site Status

Galderma Investigational Site

Beaumont, Texas, United States

Site Status

Galderma Investigational Site

Irving, Texas, United States

Site Status

Galderma Investigational Site

Pflugerville, Texas, United States

Site Status

Galderma Investigational Site

Richardson, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RD.06.SPR.118295

Identifier Type: -

Identifier Source: org_study_id