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

NCT01493947 | Completed Phase 3 Results DMC

• 1 other identifier: RD.03.SPR.40173
• Study Type: interventional
• Target: 962
• Locations: 10 countries
• Sites: 60

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

Conditions

Papulopustular Rosacea

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Time to Relapse

  Week 16 up to Week 52

Study Arms (2)

Ivermectin 1% cream

EXPERIMENTAL

Drug: Ivermectin 1% cream

Metronidazole 0.75% cream

ACTIVE COMPARATOR

Drug: Metronidazole 0.75% cream

Interventions

Ivermectin 1% cream DRUG

Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.

Also known as: Soolantra

Ivermectin 1% cream

Metronidazole 0.75% cream DRUG

Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.

Also known as: Metronidazole

Metronidazole 0.75% cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (60)

Galderma Investigational Site

Pleven, Bulgaria

Location

Galderma Investigational Site

Plovdiv, Bulgaria

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Galderma Investigational Site

Sofia, Bulgaria

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Galderma Investigational Site

Chomutov, Czechia

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Galderma Investigational Site

Hradec Králové, Czechia

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Galderma Invetigational site

Olomouc, Czechia

Location

Galderma Investigational Site

Pardubice, Czechia

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Galderma Investigational Site

Prague, 110 00, Czechia

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Galderma Investigational Site

Slaný, 27 401, Czechia

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Galderma Investigational Site

Bordeaux, France

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Galderma Investigational Site

Brest, France

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Galderma Investigational Site

Cannes, France

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Galderma Investigational Site

Nice, France

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Galderma Investigational Site

Saint-Etienne, France

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Galderma Investigational Site

Augsburg, Germany

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Galderma Investigational Site

Berlin, 13 507, Germany

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Galderma Investigational Site

Bonn, Germany

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Galderma Investigational Site

Darmstadt, 64 297, Germany

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Galderma Investigational Site

Dresden, Germany

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Galderma Investigational Site

Hamburg, Germany

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Galderma Investigational Site

Langenau, 89 129, Germany

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Galderma Investigational Site

Mahlow, 15 831, Germany

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Galderma Investigational Site

Mainz, Germany

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Galderma Investigational Site

Munich, Germany

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Galderma Investigational Site

Münster, Germany

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Galderma Investigational Site

Tübingen, Germany

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Galderma Investigational Site

Wuppertal, Germany

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Galderma Investigational Site

Budapest, 052, Hungary

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Galderma Investigational Site

Budapest, 1135, Hungary

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Galderma Investigational Site

Budapest, 1238, Hungary

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Galderma Investigational Site

Budapest, Hungary

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Galderma Investigational Site

Debrecen, 4032, Hungary

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Galderma Investigational Site

Miskolc, Hungary

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Galderma Investigational Site

Pécel, 21 19, Hungary

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Galderma Investigational Site

Szeged, Hungary

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Galderma Investigational Site

Szekszárd, Hungary

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Galderma Investigational Site

Szolnok, Hungary

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Galderma Investigational Site

Bialystok, Poland

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Galderma Investigational Site

Gdansk, Poland

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Galderma Investigational Site

Krakow, Poland

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Galderma Investigational Site

Warsaw, Poland

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Galderma Investigational Site

Wroclaw, Poland

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Galderma Investigational Site

Brasov, Romania

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Galderma Investigational Site

Bucharest, Romania

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Galderma Investigational Site

Craiova, Romania

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Galderma Investigational Site

Târgu Mureş, Romania

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Galderma Investigational Site

Timișoara, Romania

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Galderma Investigational Site

Chelyabinsk, Russia

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Galderma Investigational Site

Lipetsk, Russia

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Galderma Investigational Site

Moscow, Russia

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Galderma Investigational Site

Nizhny Novgorod, Russia

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Galderma Investigational Site

Dnipropetrovsk, Ukraine

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Galderma Investigational Site

Donetsk, Ukraine

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Galderma Investigational Site

Kiev, Ukraine

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Galderma Investigational Site

Lviv, Ukraine

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Galderma Investigational Site

Uzhhorod, Ukraine

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Galderma Investigational Site

Berkshire, United Kingdom

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Galderma Investigational Site

Bexhill-on-Sea, United Kingdom

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Galderma Investigational Site

London, United Kingdom

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Galderma Investigational Site

Nuneaton, United Kingdom

Location

MeSH Terms

Conditions

Rosacea

Interventions

Ivermectin; Metronidazole

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Galderma CPM
• Organization: Galderma R&D

clinicaltrials@galderma.com

00 33 4 93 95 70 70

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 16, 2011
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 28, 2015
• Results First Posted: October 28, 2015

Record last verified: 2015-09

Locations

BU (3); FR (5); DE (13); RO (5); GB (4); UA (5); HU (10); CZ (6); PL (5); RU (4)