CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study (ATTRACT)
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| ClinicalTrials.gov Identifier: NCT01493947 |
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Recruitment Status :
Completed
First Posted : December 16, 2011
Results First Posted : October 28, 2015
Last Update Posted : October 28, 2015
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Sponsor:
Galderma R&D
Information provided by (Responsible Party):
Galderma R&D
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Papulopustular Rosacea | Drug: Ivermectin 1% cream Drug: Metronidazole 0.75% cream | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 962 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| 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 Start Date : | April 2012 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Rosacea
MedlinePlus related topics:
Rosacea
| Arm | Intervention/treatment |
|---|---|
| Experimental: Ivermectin 1% cream |
Drug: Ivermectin 1% cream
Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
Other Name: Soolantra |
| Active Comparator: Metronidazole 0.75% cream |
Drug: Metronidazole 0.75% cream
Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Other Name: Metronidazole |
Primary Outcome Measures :
- Percent Change in Inflammatory Lesions From Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period
Other Outcome Measures:
- Time to Relapse [ Time Frame: Week 16 up to Week 52 ]Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493947
Locations
Show 60 study locations
Sponsors and Collaborators
Galderma R&D
| Responsible Party: | Galderma R&D |
| ClinicalTrials.gov Identifier: | NCT01493947 |
| Other Study ID Numbers: |
RD.03.SPR.40173 |
| First Posted: | December 16, 2011 Key Record Dates |
| Results First Posted: | October 28, 2015 |
| Last Update Posted: | October 28, 2015 |
| Last Verified: | September 2015 |
Additional relevant MeSH terms:
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Rosacea Skin Diseases Metronidazole Ivermectin |
Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents |