Benha faculty of medicine hospital
Banhā, Qaluybia, Egypt
NCT Number: NCT07763262
This randomized, split-site, within-participant controlled clinical study evaluated the efficacy and safety of a single session of autologous nanofat injection as an adjunct to narrowband ultraviolet B (NB-UVB) phototherapy in 20 adult patients with stable vitiligo. In each participant, one vitiligo site received autologous nanofat injection followed by NB-UVB phototherapy three times weekly for 3 months, while a comparable site received NB-UVB phototherapy alone. Treatment response was assessed by standardized photography performed by a blinded dermatologist, with evaluation of the onset and percentage of repigmentation, patient satisfaction, and treatment-related adverse effects.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Banhā, Qaluybia, Egypt
This randomized, split-site, within-participant controlled clinical study was conducted to evaluate the efficacy and safety of a single session of autologous nanofat injection as an adjunctive treatment to narrowband ultraviolet B (NB-UVB) phototherapy in patients with stable vitiligo.
Twenty adult patients with stable vitiligo were included, with both male and female participants eligible for enrollment. Each participant served as his or her own control. Two comparable vitiligo sites were selected in each participant. One site was treated with a single session of autologous nanofat injection followed by NB-UVB phototherapy, while the other comparable site received NB-UVB phototherapy alone.
NB-UVB phototherapy was administered three times weekly for 3 months to both treatment sites according to the study protocol. The nanofat-treated site received a single session of autologous nanofat injection before the course of NB-UVB phototherapy.
Treatment response was assessed by standardized clinical examination and serial standardized digital photographs. Photographic assessments were performed by an independent dermatologist who was blinded to the treatment allocation of the sites.
The primary efficacy assessment was based on the onset and degree of repigmentation of the treated vitiligo lesions. The percentage of repigmentation was assessed by comparison with the baseline appearance and standardized photographic documentation.
Patient satisfaction with treatment was assessed during follow-up using a predefined satisfaction scale. Treatment-related adverse effects and local or systemic reactions were recorded throughout the study period.
The study was designed to determine whether adding a single session of autologous nanofat injection to NB-UVB phototherapy provided greater or faster repigmentation than NB-UVB phototherapy alone in patients with stable vitiligo.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single session of autologous nanofat injection was performed in the randomly assigned vitiligo site. Nanofat was prepared from the participant's own adipose tissue according to the study protocol and injected into the selected vitiligo lesion.
Narrowband ultraviolet B (NB-UVB) phototherapy was administered to both the nanofat-treated and control sites three times weekly for 3 months according to the study protocol.
Time frame: Baseline to 3 months
Percentage of repigmentation of the treated vitiligo site compared with baseline, assessed using standardized clinical and photographic evaluation and compared between the nanofat-treated site and the NB-UVB-only control site.
Time frame: During the 3-month treatment period
Time to onset of clinically detectable repigmentation following initiation of treatment, comparing the nanofat-treated site with the NB-UVB-only control site.
Time frame: At the final 3-month assessment
Patient-reported satisfaction with the treatment outcome, assessed using a predefined satisfaction scale.
Time frame: From treatment initiation through 3 months
Incidence and severity of treatment-related adverse effects and local reactions associated with nanofat injection and NB-UVB phototherapy.
Benha University
Other
Evaluation of The Effect of Autologous Nanofat Injection in the Treatment of Vitiligo
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