Exploratory study to assess facial tolerability after daily application of several concentrations and formulations containing CD5789 in acne subjects

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024214-54-BE

Enrollment

Registered

2011-02-14

Start date

2011-04-28

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

Acne vulgaris MedDRA version: 13.1 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: CD5789 Product Code: CD5789 Pharmaceutical Form: Cream Current Sponsor code: CD5789 Other descriptive name: CD5789 Concentration unit: µg microgram(s) Concentration type: range Concentra

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 • If female of childbearing potential,she agrees to use a highly effective double-barrier contraception method for the duration of the study and one month after the last product application. 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 severe forms of acne requiring systemic treatment (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.) • The subject has a known allergy or sensitivity to any of the components of the study products

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the facial tolerability and subject’s adherence to treatment of different formulations of CD 5789 when applied QD over 4 weeks by acne subjects, in comparison with Tazarotene 0.1%.;Secondary Objective: Efficacy;Primary end point(s): Local Tolerability;Timepoint(s) of evaluation of this end point: At all visits	—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: At all visits	—

Countries

Belgium, Hungary

Contacts

Public ContactLynda CINQUEMANI

Galderma R&D SNC

cta.coordinator@galderma.com+33(0)4 93 95 70 85

Outcome results

None listed

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