CD5024 1% cream versus metronidazole 0.75% cream in papulopustular rosacea (PPR) study

Efficacy and safety of CD5024 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea over 16 weeks treatment, followed by a 36-week extension period

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004791-11-GB

Enrollment

960

Registered

2012-01-17

Start date

2012-03-21

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

Papulo Pustular Rosacea MedDRA version: 20.0 Level: PT Classification code 10039218 Term: Rosacea System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Code: CD5024 Pharmaceutical Form: Cream INN or Proposed INN: IVERMECTIN CAS Number: 70288-86-7 Current Sponsor code: CD5024

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female subjects 18 years of age or older at the Screening Visit, - Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA) at Screening and Baseline visits, - Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face at Screening and Baseline visits. 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 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 580

Exclusion criteria

Exclusion criteria: - Subjects with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, or seborrheic dermatitis and acne at Screening and Baseline visits, - Subjects with rosacea with more than two nodules on the face at Screening and Baseline visits.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: From baseline to week 16;Secondary Objective: ; Main Objective: Period A: To compare efficacy and safety of CD5024 1% cream applied once daily versus metronidazole 0.75% cream applied twice daily in subjects with papulopustular rosacea after 16-week topical treatment. The study is powered to detect a 10 % superiority of CD5024 1% cream over metronidazole 0.75% cream determined by percent reduction of inflammatory lesions from Baseline. Period B: To compare, for subjects initially successfully treated by 16 weeks treatment, CD5024 1% cream versus metronidazole 0.75% cream during a 36-week extension period by assessing: - The time of first relapse, - The relapse rate, - And the number of days free of treatment	—

Measure

Time frame

Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: From baseline to week 16;Secondary Objective: ; Main Objective: Period A: To compare efficacy and safety of CD5024 1% cream applied once daily versus metronidazole 0.75% cream applied twice daily in subjects with papulopustular rosacea after 16-week topical treatment. The study is powered to detect a 10 % superiority of CD5024 1% cream over metronidazole 0.75% cream determined by percent reduction of inflammatory lesions from Baseline. Period B: To compare, for subjects initially successfully treated by 16 weeks treatment, CD5024 1% cream versus metronidazole 0.75% cream during a 36-week extension period by assessing: - The time of first relapse, - The relapse rate, - And the number of days free of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Safety;Timepoint(s) of evaluation of this end point: All visits	—

Countries

Bulgaria, Czech Republic, Germany, Hungary, Russian Federation, United Kingdom

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