A double blinded, prospective, randomized, vehicle controlled, multi-center study of photodynamic therapy with Visonac cream in patients with acne vulgaris

Photocure ASA0 个研究点目标入组 150 人开始时间: 2012年3月9日最近更新: 2012年3月20日

适应症

试验速览

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•Male and female patients, aged 12 to 35 years, Fitzpatrick skin type I through VI, with 25 to 75 inflammatory and 20 to 100 non-inflammatory acne lesions, no more than 3 nodules on the face and a global acne severity score of 4.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 90
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) will be excluded. The following washout periods for prior medications apply: 14 days for topical treatment, 1 month for oral antibiotics, and 6 months for oral isotretinoin. Patients using oral contraceptive must have used the same product and dose for at least 3 months and agree to stay with the same product and dose during the study participation. Patients that have had facial procedures like dermabrasion, chemical or laser peels within the last month will be excluded. Patients using testosterone, any other systemic hormonal treatment or hormonal contraceptives solely for control of acne will be excluded. Patients using testosterone, any systemic hormonal treatment for other reasons must have used the same product and dose for at least 3 months.
•Patients with moderate, severe and very severe facial scarring will be excluded

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