CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g CREAM IN SUBJECTS WITH ACNE VULGARIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189629
• Other study ID #: RD.06.SPR.18250
• Status: Completed
• Phase: Phase 3
• Start date: February 23, 2015
• Est. completion date: February 23, 2017

Study information

• Verified date: November 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• CD5789 (trifarotene)

Locations

Country	Name	City	State
Czechia	Galderma Investigational Site	Chomutov
Czechia	Galderma Investigational site	Hradec Kralove
Czechia	Galderma Investigational Site	Olomouc
Czechia	Galderma Investigational Site	Pardubice
Czechia	Galderma Investigational site	Praha 1
Germany	Galderma Investigational Site	Augsburg
Germany	Galderma Investigational Site	Berlin
Germany	Galderma Investigational Site	Berlin
Germany	Galderma Investigational Site	Dessau
Germany	Galderma Investigational Site	Mahlow
Germany	Galderma Investigational Site	Muenster
Germany	Galderma Investigational Site	Wuppertal
Hungary	Galderma Investigational Site	Balatonfüred
Hungary	Galderma Investigational Site	Miskolc
Hungary	Galderma Investigational Site	Pécel
Hungary	Galderma Investigational Site	Szeged
Hungary	Galderma Investigational Site	Szekszard
Hungary	Galderma Investigational Site	Szolnok
United States	Galderma Investigational Site	Albuquerque	New Mexico
United States	Galderma Investigational Site	Beachwood	Ohio
United States	Galderma Investigational Site	High Point	North Carolina
United States	Galderma Investigational Site	Knoxville	Tennessee
United States	Galderma Investigational Site	Louisville	Kentucky
United States	Galderma Investigational Site	Miami	Florida
United States	Galderma Investigational Site	Miramar	Florida
United States	Galderma Investigational Site	Mobile	Alabama
United States	Galderma Investigational Site	New York	New York
United States	Galderma Investigational Site	Newnan	Georgia
United States	Galderma Investigational Site	Portland	Oregon
United States	Galderma Investigational Site	Rogers	Arkansas
United States	Galderma Investigational Site	Sacramento	California
United States	Galderma Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Czechia,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physician Global Assessment (PGA) Success Rate up to Week 52	Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).	From Baseline to Week 52