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-DE

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)