IRCT20201104049265N1
Completed
Phase 4
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 sites88 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Imen Vaccine Alborz
- Enrollment
- 88
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\-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)
Outcomes
Primary Outcomes
Not specified
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