Evaluation of The Effect of Autologous Nanofat Injection in the Treatment of Vitiligo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of Repigmentation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The participants and treating investigator were not blinded to treatment allocation. The dermatologist responsible for evaluating the standardized clinical photographs and assessing repigmentation was blinded to the treatment allocation of the individual sites.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Male or female patients.
- •Patients with clinically diagnosed stable vitiligo.
- •Presence of comparable vitiligo sites suitable for the split-site study design.
- •Ability to undergo autologous nanofat harvesting and injection.
- •Ability and willingness to undergo NB-UVB phototherapy three times weekly for 3 months.
- •Ability to comply with study follow-up and assessment procedures.
- •Provision of written informed consent.
排除标准
- •Active or progressive vitiligo.
- •Active infection or inflammation at the treatment sites.
- •Significant uncontrolled systemic disease that could interfere with treatment or assessment.
- •Contraindication to NB-UVB phototherapy.
- •Contraindication to the nanofat harvesting or injection procedure.
- •Pregnancy or breastfeeding, if this was an exclusion criterion in your protocol.
- •Previous treatment of the selected study sites that could interfere with assessment.
- •Inability to comply with the study protocol or follow-up.
- •Any condition considered by the investigator to interfere with the safety or assessment of the study.
研究组 & 干预措施
Nanofat Injection + NB-UVB
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.
干预措施: Autologous Nanofat Injection (Procedure)
NB-UVB Alone
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.
干预措施: NB-UVB Phototherapy (Other)
结局指标
主要结局
Percentage of Repigmentation
时间窗: 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.
次要结局
- Onset of Repigmentation(During the 3-month treatment period)
- Patient Satisfaction(At the final 3-month assessment)
- Treatment-Related Adverse Effects(From treatment initiation through 3 months)
研究者
karem Taha ibrahim khalil
Assistant professor Dermatology, Venereology and Andrology
Benha University