PILOT STUDY TO EXPLORE EFFICACY AND SAFETY OF DIFFERENT DOSE REGIMENS OF CD5789 IN SUBJECTS WITH ACNE VULGARIS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022211-19-DE

Enrollment

120

Registered

2010-09-23

Start date

2011-01-07

Completion date

Unknown

Last updated

2012-10-22

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

Conditions

Acne vulgaris MedDRA version: 12.1 Level: LLT Classification code 10000519 Term: Acne vulgaris

Interventions

Product Code: CD5789 Pharmaceutical Form: Gel Current Sponsor code: CD5789 Concentration unit: % percent Concentration type: equal Concentration number: 0.01- Pharmaceutical form of the placebo: Gel R

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Male or female subject aged from 18 to 35 years old * The subject has medical diagnosis of moderate to severe acne vulgaris on the face * The subject has, on the face, at least 20 inflammatory lesions and 30 non-inflammatory lesions * The Subject has a severity grade of 3 or 4 on the Investigator’s Global Assessment (IGA) scale on either side of the face Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * The subject has more than 2 acne nodules/cysts on the face * The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.) * The number of inflammatory or non inflammatory lesions on half-face is greater than twice the number on the other half-face

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the impact of different dose regimen: 5 times a week and twice a week as leave-on applications and short contact applications (5 minutes and 30 minutes), on efficacy and safety of the treatment with CD 5789 100µg/g in a gel formulation in subjects with moderate to severe acne vulgaris.;Secondary Objective: - Efficacy objectives - Safety objectives;Primary end point(s): Total acne lesion count and percent reduction at end of treatment	—

Measure

Time frame

Main Objective: To assess the impact of different dose regimen: 5 times a week and twice a week as leave-on applications and short contact applications (5 minutes and 30 minutes), on efficacy and safety of the treatment with CD 5789 100µg/g in a gel formulation in subjects with moderate to severe acne vulgaris.;Secondary Objective: - Efficacy objectives - Safety objectives;Primary end point(s): Total acne lesion count and percent reduction at end of treatment

—

Countries

Germany, Hungary

Outcome results

None listed

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