A DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY ASSESSING THE ACTIVITY OF CD5024 1% CREAM IN SUBJECTS WITH PAPULOPUSTULAR ROSACEA OVER 12 WEEKS TREATMENT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018319-13-DE

Enrollment

317

Registered

2010-06-01

Start date

2010-08-17

Completion date

Unknown

Last updated

2012-07-31

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

Conditions

PATIENTS WITH PAPULOPUSTULAR ROSACEA MedDRA version: 9.1 Level: LLT Classification code 10039218 Term: Rosacea

Interventions

Product Name: CD5024 Product Code: CD5024 Pharmaceutical Form: Cream INN or Proposed INN: Ivermectin CAS Number: 70288-86-7 Current Sponsor code: CD5024 Other descriptive name: Chemical: Avermectin Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The subject is a male or female 18 years of age or older. 2. The subject has papulopustular rosacea, with an Investigator Global Assessment (IGA), score rated = 3. 3. The subject has at least 15 inflammatory lesions (papules and pustules) on 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis. 2. The subject has ocular rosacea requiring either a systemic treatment or an interfering treatment. 3. The subject has an underlying known disease, a surgical or medical condition, which in the judgment of the investigator, would put the subject at risk, or might confound the study assessments, or might interfere with the subject’s participation in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to investigate the effect of CD5024 1% cream in subjects with Papulopustular Rosacea (PPR) in comparison to its vehicle. Subjects will apply the study treatment once a day during 12 weeks and will be followed one month after treatment stop. ;Secondary Objective: Secondary objectives are to assess the general safety of CD5024, and its efficacy versus vehicle.;Primary end point(s): Safety assessment	—

Measure

Time frame

Main Objective: The objective of the study is to investigate the effect of CD5024 1% cream in subjects with Papulopustular Rosacea (PPR) in comparison to its vehicle. Subjects will apply the study treatment once a day during 12 weeks and will be followed one month after treatment stop. ;Secondary Objective: Secondary objectives are to assess the general safety of CD5024, and its efficacy versus vehicle.;Primary end point(s): Safety assessment

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Countries

Bulgaria, Finland, Germany, Hungary

Outcome results

None listed

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