MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.

NCT02616250 | Completed Phase 4 Results

• 1 other identifier: RD.03.SPR.105069
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 13

Brief Summary

The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):

  Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)

  week 12/Hour 3

Study Arms (2)

Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream

EXPERIMENTAL

Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks. Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.

Drug: Brimonidine 0.33% gel (Br); Other: CD07805/47 (Br) placebo gel; Drug: Ivermectin 1% cream (IVM)

CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream

PLACEBO COMPARATOR

Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.

Other: CD07805/47 (Br) placebo gel; Other: CD5024 (IVM) placebo cream

Interventions

Brimonidine 0.33% gel (Br) DRUG

Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream

CD07805/47 (Br) placebo gel OTHER

Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream; CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream

Ivermectin 1% cream (IVM) DRUG

Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream

CD5024 (IVM) placebo cream OTHER

CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream

Eligibility Criteria

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

You may qualify if:

• Male or female subjects age 18 years or older;
• Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face;
• Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment \[CEA\]);
• Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment \[IGA\]);
• Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
• Female subjects of childbearing potential must practice a highly effective method of contraception during the study;
• Females subjects of non-childbearing potential;

You may not qualify if:

• Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;
• Subjects with more than 2 nodules of rosacea on the face;
• Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;
• Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (13)

Unknown Facility

Fort Smith, Arkansas, United States

Location

Unknown Facility

Rogers, Arkansas, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Pflugerville, Texas, United States

Location

Unknown Facility

Surrey, British Columbia, Canada

Location

Unknown Facility

Markham, Ontario, Canada

Location

Unknown Facility

Peterborough, Ontario, Canada

Location

Unknown Facility

Richmond Hill, Ontario, Canada

Location

Unknown Facility

Waterloo, Ontario, Canada

Location

Unknown Facility

Windsor, Ontario, Canada

Location

MeSH Terms

Conditions

Rosacea

Interventions

Brimonidine Tartrate; Gels; Ivermectin; Intravital Microscopy

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Macrolides; Polyketides; Lactones; Organic Chemicals; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Fabien AUDIBERT, Sr CPM
• Organization: GALDERMA

fabien.audibert@galderma.com

+33 (0) 4 9238 3034

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 18, 2021
• Results First Posted: October 19, 2017

Record last verified: 2018-02

Locations

US (7); CA (6)