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IRCT20201104049265N1 IRCT 2021-07-08 Imen Vaccine Alborz Phase IV Clinical Trial to Evaluate the Efficacy and Safety of basic Fibroblast Growth Factor Compared to Placebo in Combination with NBUVB for the Treatment of Vitiligo 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 2021-07-10 anticipated 88 Complete https://irct.ir/trial/57246 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into 2 groups. Both groups will be treated equally with phototherapy (NBUVB), the intervention group will administer bFGF serum and the control group will administer the vehicle. Roller bottles are not different in appearance; Therefore, patients will not be able to distinguish the bFGF-containing roller from the vehicle. Sealedenvelope.com and has been used to create a list of random codes with block sizes of four, Blinding description: As the serum containing bFGF and the vehicle are completely alike in their appearance, and the method and timing of administration are the same, it is expected that both the patient and the physician are unaware of receiving bFGF or vehicle. In this study, in addition to the physician and the patients, the outcome assessor will also be blind to the assigned interventions, and therefore the study will be performed as a triple-blind phase IV clinical trial. 4 Vitiligo. Intervention 1: Intervention group: BFGF serum that is administered topically to the lesions every night and the patient will be exposed to sunlight for 5 to 10 minutes the next day between 11 AM and 15 PM. Intervention 2: Control group: Vehicle (placebo) that is administered topically on the lesions every night and the patient will be exposed to sunlight for 5 to 10 minutes the next day between 11 AM and 15 PM. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available
public Dr. Setayesh Sadeghi
West side of Sheikh Baha'i Square, Ryan Vanak Building, No. 18, 6th floor, Unit 603
Tehran Iran (Islamic Republic of) 1993873057 +98 21 8609 2794 s.sadeghi@artapharmed.com Arta Zist Pharmed scientific Amir Houshang Ehsani
Vahdat Eslami Square, Tehran, Iran.
Tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 21 5563 0553 ehsanih@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) - 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 18 years 65 years Both - 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) L80 Vitiligo Treatment - Drugs Placebo Intervention group: BFGF serum that is administered topically to the lesions every night and the patient will be exposed to sunlight for 5 to 10 minutes the next day between 11 AM and 15 PM. Control group: Vehicle (placebo) that is administered topically on the lesions every night and the patient will be exposed to sunlight for 5 to 10 minutes the next day between 11 AM and 15 PM. Percentage of repigmentation. Timepoint: Baseline, week 6, and week 16. Method of measurement: Comparison of photos taken from lesions. Patients' satisfaction score. Timepoint: Baseline, week 6, and week 16. Method of measurement: Asking the patient to rate their satisfaction from a scale of 0 to 10 points. Occurrence of any adverse reactions or adverse events. Timepoint: Throughout the study period. Method of measurement: Dairy card distribution. Imen Vaccine Alborz Approved 2021-07-03 Ethics committee of Tehran University of Medical Sciences Vahdat Eslami Square, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)