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

Evaluating the efficacy and safety of bFGF in combination with NBUVB for the treatment vitiligo

This study will be performed as an active post marketing surveillance phase 4, triple-blind (patient, physician and outcome assessor), placebo-controlled study with a superiority approach to evaluate the efficacy and safety of bFGF peptide serum in the treatment of vitiligo patches on the face.

Razi Hospital, Tehran, Iran

Inclusion criteria: Male or females aged 18 to 65, signed the informed consent form, Diagnosis of non-segmental vitiligo not more than 5 years, Stable vitiligo for at least 6 months, Candidate for phototherapy, 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 Exclusion criteria: Women of childbearing potential, or breastfeeding, 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, Patients with known allergy to the product's excipients

One group receives bFGF peptide serum and the other will only receive vehicles (both will be treated with NBUVB during the study)

Percentage of repigmentation by comparing photos taken from facial lesions

Change in the study title (after ethics committee approval)

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.

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.