Active Post Marketing Surveillance to Evaluate the Efficacy and Safety of bFGF in Combination with NBUVB for the Treatment of Vitiligo; A Triple-blind, Randomized, Placebo-controlled Clinical Trial

Imen Vaccine Alborz0 个研究点目标入组 88 人开始时间: 待定最近更新: 2021年11月1日

试验速览

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•Male or female patients aged 18 to 65 years
•-Willingly signed the written informed consent form
•-Diagnosis of non-segmental vitiligo no longer than 5 years with symmetrical lesions except for the eyelids
•-Stable vitiligo for at least 6 months (no new patches, or less than 10% increase in the diameter of the existing patches for at least 6 months
•-Candidate for phototherapy (more than 25% body surface involvement)
•-Have not been receiving any topical or systemic treatments for vitiligo for the past 6 weeks
•-Have not been receiving phototherapy during the past 6 months
•-Not having any physical or mental conditions that would interfere with the patient’s participation in the study or endanger their safety in the opinion of the investigator
•-Patients with general good health (except vitiligo) as judged by the Investigator

•-Women of childbearing potential, or breastfeeding women
•-Diagnosis of extensive or unstable vitiligo
•-Patients with skin cancer or precancerous skin lesions
•-Patients with poliosis in > 50% of their vitiligo patches
•-Patients with complete facial depigmentation
•-Diagnosis of segmental or mixed vitiligo
•-Subjects whose vitiligo has not responded to phototherapy or patients who have received phototherapy in the past 6 months
•-Patients with contraindication to NBUVB (pemphigus, Systemic Lupus Erythematosus, cataract, Xeroderma pigmentosum, patients receiving immunosuppressants due to organ transplantation, excessive photosensitivity)
•-Patients with known allergy to the product's ingredients and excipients (isopropyl alcohol, propylene glycol, isopropyl myristate, and phenoxy ethanol)

发起方

Imen Vaccine Alborz