Studying the Effects of 50µg/g Cream versus Placebo on Patients who have Acne

A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris - Double-Blind Efficacy and Safety of CD5789 50µg/g Cream versus Vehicle cream in acne vulgaris

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002860-15-DE

Enrollment

1200

Registered

2016-10-20

Start date

2017-01-24

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris MedDRA version: 20.0 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858

Interventions

Product Name: Trifarotene Product Code: CD5789 Pharmaceutical Form: Cream INN or Proposed INN: Trifarotene CAS Number: 895542-09-3 Current Sponsor code: CD5789 Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female, 9 years of age and older), at the Screening visit. For Russia: Male or female, 9-17 years of age OR 18 years and older, at the Screening visit - The Subject has a facial acne severity grade of 3 (moderate) on the Investigator Global Assessment (IGA) scale at Screening and Baseline. - The subject has a minimum of 20 inflammatory lesions and 25 noninflammatory lesions on the face at Screening and Baseline. Are the trial subjects under 18? yes Number of subjects for this age range: 1200 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 622 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: - The subject has severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.). - The subject has more than 1 nodule on the face at Screening and Baseline. - The subject has more than 1 nodule on the trunk at Screening and Baseline.

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of the efficacy and safety of CD5789 50µg/g cream applied once daily for 12 weeks in subjects with moderate facial and truncal acne vulgaris.;Secondary Objective: Not applicable;Primary end point(s): 1) Success Rate, defined as the percentage of subjects who achieve an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement 2) Absolute Change in facial non-inflammatory lesion count. 3) Absolute Change in facial inflammatory lesion count;Timepoint(s) of evaluation of this end point: 1) from Baseline to Week 12 2) from Baseline to Week 12 3) from Baseline to Week 12	—

Measure

Time frame

Main Objective: Assessment of the efficacy and safety of CD5789 50µg/g cream applied once daily for 12 weeks in subjects with moderate facial and truncal acne vulgaris.;Secondary Objective: Not applicable;Primary end point(s): 1) Success Rate, defined as the percentage of subjects who achieve an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement 2) Absolute Change in facial non-inflammatory lesion count. 3) Absolute Change in facial inflammatory lesion count;Timepoint(s) of evaluation of this end point: 1) from Baseline to Week 12 2) from Baseline to Week 12 3) from Baseline to Week 12

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Percentage of subjects who achieve a PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2 grade improvement 2) Absolute change in truncal non-inflammatory lesion count 3) Absolute change in truncal inflammatory lesion count;Timepoint(s) of evaluation of this end point: 1) from Baseline to Week 12 2) from Baseline to Week 12 3) from Baseline to Week 12	—

Countries

Canada, Czech Republic, Germany, Hungary, Poland, Puerto Rico, Russian Federation, United States

Contacts

Public ContactCTA Coordinator

Galderma R&D SNC

cta.coordinator@galderma.com+33(0)493 95 70 85

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026