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
- Conditions
- Vitiligo.Vitiligo
- Registration Number
- IRCT20201104049265N1
- Lead Sponsor
- Imen Vaccine Alborz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 88
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of repigmentation. Timepoint: Baseline, week 6, and week 16. Method of measurement: Comparison of photos taken from lesions.
- Secondary Outcome Measures
Name Time Method 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.