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

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

EUCTR2015-002540-13-ES

Enrollment

1200

Registered

2015-10-30

Start date

2016-02-09

Completion date

Unknown

Last updated

2017-05-29

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

Conditions

Acne Vulgaris MedDRA version: 18.1 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858

Interventions

Product Code: CD5789 Pharmaceutical Form: Cream INN or Proposed INN: Trifarotene CAS Number: 895542-09-3 Current Sponsor code: CD5789 Concentration unit: µg/kg microgram(s)/kilogram Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female, 9 years of age and older, at the Screening visit. 2. The Subject has a facial acne severity grade of 3 (moderate) on the Investigator Global Assessment (IGA) scale at Screening and Baseline. 3. The subject has a minimum of 20 inflammatory lesions and 25 noninflammatory lesions on the face at Screening and Baseline. 4. The subject has truncal acne severity grade of 3 (moderate) on the Physician Global assessment (PGA) scale at Screening and Baseline visits on trunk (shoulders, upper back and upper anterior chest) reachable for self-application of study drug by the subject (optional criterion for subject between 9 and 11 years of age). Are the trial subjects under 18? yes Number of subjects for this age range: 720 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 478 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: 1. The subject has severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.). 2. The subject has more than 1 nodule on the face at Screening and Baseline. 3. The subject has more than 1 nodule on the trunk at Screening and Baseline 4. The subject has any acne cysts on the trunk at Screening and at 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

Czech Republic, Hungary, Poland, Romania, Russian Federation, Spain, Ukraine, United States

Contacts

Public ContactRicardo Diaz (General Director)

Chiltern International Spain S.A.

spain.regulatory@chiltern.com+3491187 27 00

Outcome results

None listed

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