CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study

Papulopustular Rosacea Clinical Trial

— ATTRACT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493947
• Other study ID #: RD.03.SPR.40173
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2011
• Last updated: September 22, 2015
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2015
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesGermany: Ethics CommissionGermany: Ministry of HealthUnited Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBulgaria: Ethics committeeBulgaria: Bulgarian Drug AgencyCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlHungary: Ministry of Health, Social and Family AffairsHungary: Research Ethics Medical CommitteePoland: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: Ethics CommitteeRomania: National Medicines AgencyRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationUkraine: Ethics CommitteeUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 962
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• Ivermectin 1% cream
Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
• Metronidazole 0.75% cream
Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.

Locations

Country	Name	City	State
Bulgaria	Galderma Investigational Site	Pleven
Bulgaria	Galderma Investigational Site	Plovdiv
Bulgaria	Galderma Investigational Site	Sofia
Czech Republic	Galderma Investigational Site	Chomutov
Czech Republic	Galderma Investigational Site	Hradec Kralove
Czech Republic	Galderma Invetigational site	Olomouc
Czech Republic	Galderma Investigational Site	Pardubice
Czech Republic	Galderma Investigational Site	Praha 1
Czech Republic	Galderma Investigational Site	Slany
France	Galderma Investigational Site	Bordeaux
France	Galderma Investigational Site	Brest
France	Galderma Investigational Site	Cannes
France	Galderma Investigational Site	Nice
France	Galderma Investigational Site	Saint Etienne
Germany	Galderma Investigational Site	Augsburg
Germany	Galderma Investigational Site	Berlin
Germany	Galderma Investigational Site	Bonn
Germany	Galderma Investigational Site	Darmstadt
Germany	Galderma Investigational Site	Dresden
Germany	Galderma Investigational Site	Hamburg
Germany	Galderma Investigational Site	Langenau
Germany	Galderma Investigational Site	Mahlow
Germany	Galderma Investigational Site	Mainz
Germany	Galderma Investigational Site	Munich
Germany	Galderma Investigational Site	Munster
Germany	Galderma Investigational Site	Tubingen
Germany	Galderma Investigational Site	Wuppertal
Hungary	Galderma Investigational Site	Budapest
Hungary	Galderma Investigational Site	Budapest
Hungary	Galderma Investigational Site	Budapest
Hungary	Galderma Investigational Site	Budapest
Hungary	Galderma Investigational Site	Debrecen
Hungary	Galderma Investigational Site	Miskolc
Hungary	Galderma Investigational Site	Pecel
Hungary	Galderma Investigational Site	Szeged
Hungary	Galderma Investigational Site	Szekszard
Hungary	Galderma Investigational Site	Szolnok
Poland	Galderma Investigational Site	Bialystok
Poland	Galderma Investigational Site	Gdansk
Poland	Galderma Investigational Site	Krakow
Poland	Galderma Investigational Site	Warszawa
Poland	Galderma Investigational Site	Wroclaw
Romania	Galderma Investigational Site	Brasov
Romania	Galderma Investigational Site	Bucharest
Romania	Galderma Investigational Site	Craiova
Romania	Galderma Investigational Site	Timisoara
Romania	Galderma Investigational Site	Tirgu Mures
Russian Federation	Galderma Investigational Site	Chelyabinsk
Russian Federation	Galderma Investigational Site	Lipetsk
Russian Federation	Galderma Investigational Site	Moscow
Russian Federation	Galderma Investigational Site	Nizhny Novgorod
Ukraine	Galderma Investigational Site	Dnipropetrovsk
Ukraine	Galderma Investigational Site	Donetsk
Ukraine	Galderma Investigational Site	Kiev
Ukraine	Galderma Investigational Site	Lviv
Ukraine	Galderma Investigational Site	Uzhgorod
United Kingdom	Galderma Investigational Site	Berkshire
United Kingdom	Galderma Investigational Site	Bexhill
United Kingdom	Galderma Investigational Site	London
United Kingdom	Galderma Investigational Site	Nuneaton

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  France,  Germany,  Hungary,  Poland,  Romania,  Russian Federation,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Relapse	Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.	Week 16 up to Week 52	No
Primary	Percent Change in Inflammatory Lesions From Baseline to Week 16	Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period	Baseline and Week 16	No