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

Primary Purpose

Papulopustular Rosacea

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ivermectin 1% cream
Metronidazole 0.75% cream
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papulopustular Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Invetigational site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
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  • Galderma Investigational Site
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  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ivermectin 1% cream

Metronidazole 0.75% cream

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 15, 2011
Last Updated
September 22, 2015
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01493947
Brief Title
CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
962 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivermectin 1% cream
Arm Type
Experimental
Arm Title
Metronidazole 0.75% cream
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ivermectin 1% cream
Other Intervention Name(s)
Soolantra
Intervention Description
Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
Intervention Type
Drug
Intervention Name(s)
Metronidazole 0.75% cream
Other Intervention Name(s)
Metronidazole
Intervention Description
Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Primary Outcome Measure Information:
Title
Percent Change in Inflammatory Lesions From Baseline to Week 16
Description
Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period
Time Frame
Baseline and Week 16
Other Pre-specified Outcome Measures:
Title
Time to Relapse
Description
Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.
Time Frame
Week 16 up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Galderma Investigational Site
City
Pleven
Country
Bulgaria
Facility Name
Galderma Investigational Site
City
Plovdiv
Country
Bulgaria
Facility Name
Galderma Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
Galderma Investigational Site
City
Chomutov
Country
Czech Republic
Facility Name
Galderma Investigational Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Galderma Invetigational site
City
Olomouc
Country
Czech Republic
Facility Name
Galderma Investigational Site
City
Pardubice
Country
Czech Republic
Facility Name
Galderma Investigational Site
City
Praha 1
ZIP/Postal Code
110 00
Country
Czech Republic
Facility Name
Galderma Investigational Site
City
Slany
ZIP/Postal Code
27 401
Country
Czech Republic
Facility Name
Galderma Investigational Site
City
Bordeaux
Country
France
Facility Name
Galderma Investigational Site
City
Brest
Country
France
Facility Name
Galderma Investigational Site
City
Cannes
Country
France
Facility Name
Galderma Investigational Site
City
Nice
Country
France
Facility Name
Galderma Investigational Site
City
Saint Etienne
Country
France
Facility Name
Galderma Investigational Site
City
Augsburg
Country
Germany
Facility Name
Galderma Investigational Site
City
Berlin
ZIP/Postal Code
13 507
Country
Germany
Facility Name
Galderma Investigational Site
City
Bonn
Country
Germany
Facility Name
Galderma Investigational Site
City
Darmstadt
ZIP/Postal Code
64 297
Country
Germany
Facility Name
Galderma Investigational Site
City
Dresden
Country
Germany
Facility Name
Galderma Investigational Site
City
Hamburg
Country
Germany
Facility Name
Galderma Investigational Site
City
Langenau
ZIP/Postal Code
89 129
Country
Germany
Facility Name
Galderma Investigational Site
City
Mahlow
ZIP/Postal Code
15 831
Country
Germany
Facility Name
Galderma Investigational Site
City
Mainz
Country
Germany
Facility Name
Galderma Investigational Site
City
Munich
Country
Germany
Facility Name
Galderma Investigational Site
City
Munster
Country
Germany
Facility Name
Galderma Investigational Site
City
Tubingen
Country
Germany
Facility Name
Galderma Investigational Site
City
Wuppertal
Country
Germany
Facility Name
Galderma Investigational Site
City
Budapest
ZIP/Postal Code
052
Country
Hungary
Facility Name
Galderma Investigational Site
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Galderma Investigational Site
City
Budapest
ZIP/Postal Code
1238
Country
Hungary
Facility Name
Galderma Investigational Site
City
Budapest
Country
Hungary
Facility Name
Galderma Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Galderma Investigational Site
City
Miskolc
Country
Hungary
Facility Name
Galderma Investigational Site
City
Pecel
ZIP/Postal Code
21 19
Country
Hungary
Facility Name
Galderma Investigational Site
City
Szeged
Country
Hungary
Facility Name
Galderma Investigational Site
City
Szekszard
Country
Hungary
Facility Name
Galderma Investigational Site
City
Szolnok
Country
Hungary
Facility Name
Galderma Investigational Site
City
Bialystok
Country
Poland
Facility Name
Galderma Investigational Site
City
Gdansk
Country
Poland
Facility Name
Galderma Investigational Site
City
Krakow
Country
Poland
Facility Name
Galderma Investigational Site
City
Warszawa
Country
Poland
Facility Name
Galderma Investigational Site
City
Wroclaw
Country
Poland
Facility Name
Galderma Investigational Site
City
Brasov
Country
Romania
Facility Name
Galderma Investigational Site
City
Bucharest
Country
Romania
Facility Name
Galderma Investigational Site
City
Craiova
Country
Romania
Facility Name
Galderma Investigational Site
City
Timisoara
Country
Romania
Facility Name
Galderma Investigational Site
City
Tirgu Mures
Country
Romania
Facility Name
Galderma Investigational Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
Lipetsk
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Galderma Investigational Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Donetsk
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Kiev
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Lviv
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Uzhgorod
Country
Ukraine
Facility Name
Galderma Investigational Site
City
Berkshire
Country
United Kingdom
Facility Name
Galderma Investigational Site
City
Bexhill
Country
United Kingdom
Facility Name
Galderma Investigational Site
City
London
Country
United Kingdom
Facility Name
Galderma Investigational Site
City
Nuneaton
Country
United Kingdom

12. IPD Sharing Statement

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

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