Investigation of the effectiveness, tolerability and safety of ilon® Salbe classic in the treatment of acute inflammation of the hair follicle (folliculitis) - Prospective, open, evaluator-blinded, randomized, placebo-controlled multicenter trialInvestigation of the effectiveness, tolerability and safety of ilon® Salbe classic in the treatment of acute inflammation of the hair follicle (folliculitis) - Prospective, open, randomized, placebo-/comparator controlled multicenter trial (previous title – feasibility study)

Cesra Arzneimittel GmbH & Co.KG0 个研究点目标入组 130 人开始时间: 2017年3月2日最近更新: 2022年5月9日

适应症

试验速览

暂无简介。

•- Caucasian
•- Age 18 – 80 years
•- Gender: female or male
•- Acute folliculitis with 2 to 12 hair folliculitis lesions in a defined area of 5x5 cm
•- Actively cooperating to participate in the trial, to follow the instructions of the Investigator and to attend the agreed visits.
•- Patient has signed the consent form after the nature of the trial was fully explained by the Investigator and understood by the patient.
•- At least one evaluable photograph of the skin area to be treated has been taken at visit 1.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Presence of skin lesions, e.g. open wounds or ulcers in the respective skin area
•- Presence of acne in the respective skin area
•- Presence of potential fungal or viral caused skin infections (e.g. Malassezia caused dermatitis)
•- Presence of skin diseases other than acute folliculitis and interfering with study treatment
•- Treatment with epidermal growth factor receptor (EGFR) inhibitors
•- Topical use of any dermatological product (e.g. medications, medicinal products, cosmetic products) on the trial areas during the trial.
•- Any systemic or topical immunosuppressive therapy (e.g. corticosteroids) within 3 weeks prior to randomization.
•- Congenital or acquired immunodeficiency
•- Participation in any other trial within 30 days prior to randomization or during the trial.
•- Contraindications to any component of the study medication.
•- Known allergy or intolerance to any component of the study medication
•- History of drug, alcohol or chemical abuse
•- Other(s), considered as important by the Investigator (e.g. multiple naevi in trial area, important hair growth in trial area, pigmented skin impairing visual assessment etc.).
•- Pregnant or lactating females

发起方