severe Rosacea MedDRA version: 20.0 Level: PT Classification code 10039218 Term: Rosacea System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Soolantra
Product Name: Soolantra
Product Code: CD5024
Pharmaceutical Form: Cream
INN or Proposed INN: Ivermectin
CAS Number: 70288-86-7
Current Sponsor code: CD5024
Other descriptive name
Sponsors
Galderma R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject age = 18 years or older 2. Subject with a minimum of 20 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face at Baseline visit 3. Subject with severe rosacea with papulopustular lesions (according to the Investigator’s Global Assessment, IGA score rated 4) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Subject with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated pustulosis of the chin, isolated rhinophyma) or other facial dermatoses that may be confounded with papulopustular rosacea, such as perioral dermatitis, facial keratosis pilaris, acute lupus erythematosus, actinic telangiectasia or seborrheic dermatitis and acne vulgaris 2. Subject with more than 2 nodules of rosacea (a circumscribed, elevated, solid lesion more than 1.0cm in diameter with palpable depth) on the face 3. Subject with known allergies or sensitivities to any components of the formulation of the study drugs being tested (either Ivermectin 1% cream or Doxycycline, see package inserts)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Percent change from Baseline in Inflammatory Lesion count 2 - CEA % of subjects across scores 3 - IGA % of subjects across scores 4 - Stinging/burning % of subjects across scores 5 -Percent change from Baseline (medical history) in terms of flushing count 6 -Change from Baseline (medical history) in terms of flushing severity score 7 -Global improvement in rosacea % of subjects across scores ;Timepoint(s) of evaluation of this end point: 1 - at each intermediate visit 2 - at each post-Baseline visit 3 - at each post-Baseline visit 4 - at each post-Baseline visit 5 - per week over 12 weeks 6- per week over 12 weeks 7 - at the last visit | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical cream associated with Placebo in the treatment of severe Rosacea. ;Secondary Objective: The Safety and Patient Reported Outcomes (PRO) will be also evaluated ;Primary end point(s): The percent change from Baseline in Inflammatory Lesion count ;Timepoint(s) of evaluation of this end point: at Week 12 | — |
Countries
Canada, Czech Republic, Germany, Hungary, Poland, United States
Contacts
Public ContactCTA Coordinator
GALDERMA R&D SNC
Outcome results
None listed