Vitiligo. Vitiligo
Conditions
Interventions
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
Sponsors
Imen Vaccine Alborz
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of repigmentation. Timepoint: Baseline, week 6, and week 16. Method of measurement: Comparison of photos taken from lesions. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Setayesh Sadeghi
Arta Zist Pharmed
Outcome results
None listed