Clinical trial NCT01493947: CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papulopustular Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-12-16
Enrollment: 962
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study objectives:

* To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment.
* And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 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


Eligibility criteria: Inclusion Criteria:

* Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA),
* Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.

Exclusion Criteria:

* Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilar, or seborrheic dermatitis and acne,
* Subjects with rosacea with more than two nodules on the face.

Primary outcomes:
measure: Percent Change in Inflammatory Lesions From Baseline to Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
Other outcomes:
measure: Time to Relapse
timeFrame: Week 16 up to Week 52
Locations:
city: Pleven
country: Bulgaria
facility: Galderma Investigational Site
city: Plovdiv
country: Bulgaria
facility: Galderma Investigational Site
city: Sofia
country: Bulgaria
facility: Galderma Investigational Site
city: Chomutov
country: Czech Republic
facility: Galderma Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: Galderma Investigational Site
city: Olomouc
country: Czech Republic
facility: Galderma Invetigational site
city: Pardubice
country: Czech Republic
facility: Galderma Investigational Site
city: Praha 1
country: Czech Republic
facility: Galderma Investigational Site
city: Slany
country: Czech Republic
facility: Galderma Investigational Site
city: Bordeaux
country: France
facility: Galderma Investigational Site
city: Brest
country: France
facility: Galderma Investigational Site
city: Cannes
country: France
facility: Galderma Investigational Site
city: Nice
country: France
facility: Galderma Investigational Site
city: Saint Etienne
country: France
facility: Galderma Investigational Site
city: Augsburg
country: Germany
facility: Galderma Investigational Site
city: Berlin
country: Germany
facility: Galderma Investigational Site
city: Bonn
country: Germany
facility: Galderma Investigational Site
city: Darmstadt
country: Germany
facility: Galderma Investigational Site
city: Dresden
country: Germany
facility: Galderma Investigational Site
city: Hamburg
country: Germany
facility: Galderma Investigational Site
city: Langenau
country: Germany
facility: Galderma Investigational Site
city: Mahlow
country: Germany
facility: Galderma Investigational Site
city: Mainz
country: Germany
facility: Galderma Investigational Site
city: Munich
country: Germany
facility: Galderma Investigational Site
city: Munster
country: Germany
facility: Galderma Investigational Site
city: Tubingen
country: Germany
facility: Galderma Investigational Site
city: Wuppertal
country: Germany
facility: Galderma Investigational Site
city: Budapest
country: Hungary
facility: Galderma Investigational Site
city: Budapest
country: Hungary
facility: Galderma Investigational Site
city: Budapest
country: Hungary
facility: Galderma Investigational Site
city: Budapest
country: Hungary
facility: Galderma Investigational Site
city: Debrecen
country: Hungary
facility: Galderma Investigational Site
city: Miskolc
country: Hungary
facility: Galderma Investigational Site
city: Pecel
country: Hungary
facility: Galderma Investigational Site
city: Szeged
country: Hungary
facility: Galderma Investigational Site
city: Szekszard
country: Hungary
facility: Galderma Investigational Site
city: Szolnok
country: Hungary
facility: Galderma Investigational Site
city: Bialystok
country: Poland
facility: Galderma Investigational Site
city: Gdansk
country: Poland
facility: Galderma Investigational Site
city: Krakow
country: Poland
facility: Galderma Investigational Site
city: Warszawa
country: Poland
facility: Galderma Investigational Site
city: Wroclaw
country: Poland
facility: Galderma Investigational Site
city: Brasov
country: Romania
facility: Galderma Investigational Site
city: Bucharest
country: Romania
facility: Galderma Investigational Site
city: Craiova
country: Romania
facility: Galderma Investigational Site
city: Timisoara
country: Romania
facility: Galderma Investigational Site
city: Tirgu Mures
country: Romania
facility: Galderma Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: Galderma Investigational Site
city: Lipetsk
country: Russian Federation
facility: Galderma Investigational Site
city: Moscow
country: Russian Federation
facility: Galderma Investigational Site
city: Nizhny Novgorod
country: Russian Federation
facility: Galderma Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Galderma Investigational Site
city: Donetsk
country: Ukraine
facility: Galderma Investigational Site
city: Kiev
country: Ukraine
facility: Galderma Investigational Site
city: Lviv
country: Ukraine
facility: Galderma Investigational Site
city: Uzhgorod
country: Ukraine
facility: Galderma Investigational Site
city: Berkshire
country: United Kingdom
facility: Galderma Investigational Site
city: Bexhill
country: United Kingdom
facility: Galderma Investigational Site
city: London
country: United Kingdom
facility: Galderma Investigational Site
city: Nuneaton
country: United Kingdom
facility: Galderma Investigational Site
Study officials:
References: