Oracea Soolantra association in patients with severe rosacea

Phase 1

Conditions: severe Rosacea
MedDRA version: 20.0Level: PTClassification code 10039218Term: RosaceaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2017-000157-40-HU

Lead Sponsor: Galderma R&D SNC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 270

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

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>;Secondary Objective: The Safety and Patient Reported Outcomes (PRO) will be also evaluated<br>;Primary end point(s): The percent change from Baseline in Inflammatory Lesion count ;Timepoint(s) of evaluation of this end point: at Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1 - Percent change from Baseline in Inflammatory Lesion count <br>2 - CEA % of subjects across scores <br>3 - IGA % of subjects across scores <br>4 - Stinging/burning % of subjects across scores<br>5 -Percent change from Baseline (medical history) in terms of flushing count <br>6 -Change from Baseline (medical history) in terms of flushing severity score <br>7 -Global improvement in rosacea % of subjects across scores <br>;Timepoint(s) of evaluation of this end point: 1 - at each intermediate visit<br>2 - at each post-Baseline visit <br>3 - at each post-Baseline visit<br>4 - at each post-Baseline visit<br>5 - per week over 12 weeks<br>6- per week over 12 weeks<br>7 - at the last visit