NCT02189629

Brief Summary

Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
453

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2015

Geographic Reach
4 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

February 23, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

September 17, 2019

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

July 11, 2014

Results QC Date

April 18, 2019

Last Update Submit

November 12, 2019

Conditions

Acne Vulgaris

Keywords

Acne vulgarisSafetyFaceTrunk

Outcome Measures

Primary Outcomes (1)

  • Investigator Global Assessment (IGA) Success Rate up to Week 52

    Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).

    From Baseline to Week 52

Secondary Outcomes (1)

  • Physician Global Assessment (PGA) Success Rate up to Week 52

    From Baseline to Week 52

Study Arms (1)

CD5789 (trifarotene) cream

EXPERIMENTAL
Drug: CD5789 (trifarotene)

Interventions

CD5789 (trifarotene)DRUG
CD5789 (trifarotene) cream

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits.
  • The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face.

You may not qualify if:

  • The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.).
  • The Subject has more than 1 nodule on the face at Screening and at Baseline visits.
  • The Subject has any acne cyst on the face at Screening and at Baseline visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Galderma Investigational Site

Mobile, Alabama, 36608, United States

Location

Galderma Investigational Site

Rogers, Arkansas, 72758, United States

Location

Galderma Investigational Site

Sacramento, California, 95819, United States

Location

Galderma Investigational Site

San Diego, California, 92123, United States

Location

Galderma Investigational Site

Miami, Florida, 33175, United States

Location

Galderma Investigational Site

Miramar, Florida, 33027, United States

Location

Galderma Investigational Site

Newnan, Georgia, 30277, United States

Location

Galderma Investigational Site

Louisville, Kentucky, 40241, United States

Location

Galderma Investigational Site

Albuquerque, New Mexico, 87107, United States

Location

Galderma Investigational Site

New York, New York, 10155, United States

Location

Galderma Investigational Site

High Point, North Carolina, 27262, United States

Location

Galderma Investigational Site

Beachwood, Ohio, 44122, United States

Location

Galderma Investigational Site

Portland, Oregon, 97210, United States

Location

Galderma Investigational Site

Knoxville, Tennessee, 37922, United States

Location

Galderma Investigational Site

Chomutov, 430 04, Czechia

Location

Galderma Investigational site

Hradec Králové, 500 05, Czechia

Location

Galderma Investigational Site

Olomouc, 775 20, Czechia

Location

Galderma Investigational Site

Pardubice, 532 03, Czechia

Location

Galderma Investigational site

Prague, 110 00, Czechia

Location

Galderma Investigational Site

Augsburg, 86179, Germany

Location

Galderma Investigational Site

Berlin, 10117, Germany

Location

Galderma Investigational Site

Berlin, 13507, Germany

Location

Galderma Investigational Site

Dessau, 06847, Germany

Location

Galderma Investigational Site

Mahlow, 15831, Germany

Location

Galderma Investigational Site

Münster, 48149, Germany

Location

Galderma Investigational Site

Wuppertal, 42287, Germany

Location

Galderma Investigational Site

Balatonfüred, 8230, Hungary

Location

Galderma Investigational Site

Miskolc, 3529, Hungary

Location

Galderma Investigational Site

Pécel, 2119, Hungary

Location

Galderma Investigational Site

Szeged, 6720, Hungary

Location

Galderma Investigational Site

Szekszárd, 7100, Hungary

Location

Galderma Investigational Site

Szolnok, 5000, Hungary

Location

MeSH Terms

Conditions

Acne VulgarisFacies

Interventions

trifarotene

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Anne Fulton
Organization
Galderma S.A.
anne.fulton@galderma.com
+1 817-961-5203

Study Officials

  • Kevin Chan

    Galderma R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 14, 2014

Study Start

February 23, 2015

Primary Completion

February 23, 2017

Study Completion

February 23, 2017

Last Updated

November 14, 2019

Results First Posted

September 17, 2019

Record last verified: 2019-11

Locations

CZ(5)HU(6)US(14)DE(7)