Efficacy comparison 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. - ANSWER study - oraceA soolaNtra aSsociation in patients With severE Rosacea

Galderma R&D SNC0 个研究点目标入组 270 人开始时间: 2017年5月4日最近更新: 2018年4月30日

研究概览

暂无简介。

•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

•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)

发起方

Galderma R&D SNC