A Clinical and Immunological Study of Phototoxic Doses of Ultraviolet A for Treatment of Alopecia Areata: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treatment success
研究概览
简要总结
Alopecia areata (AA) is a disease of the hair follicles with multifactorial etiology and a strong component of autoimmune origin. It is characterized by non-scarring hair loss on the scalp or any hair-bearing surface.
Various therapeutic agents have been described for the treatment of AA, but none are curative or preventive. The aim of AA treatment is to suppress the activity of the disease. Phototherapy in the form of topical psoralen and ultraviolet A (PUVA) has been a well documented therapy for AA since 1978.
A more recent technique of topical PUVA, namely phototoxic PUVA, has been adopted in two previous studies. Sessions were carried out once every 3 months, and a higher efficacy with more encouraging response rates in comparison to the conventional PUVA therapy has been documented. This assumed upper hand over the conventional PUVA might be due to increasing the amount of UV reaching the hair follicle cells and the surrounding inflammatory cells. Also it has been suggested that it might play a role as a powerful initiating agent of suppression through direct action at the DNA level. However, still the exact effect of this treatment has not been fully clarified.
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)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with alopecia areata, patchy type (max 3 patches not exceeding 50% of the scalp surface area) of more than 2 months duration.
- •Age: 12 years and above
排除标准
- •Age: Less than 12 years old.
- •Affection of more than 50% of the scalp area
- •Diagnosis or history of local dermatological disease in the scalp apart from AA such as eczema, seborrheic dermatitis, psoriasis,..
- •Any present / past history of dermatological disease with a potential for koebnerization such as psoriasis, vitiligo.
- •Diagnosis or history of any contraindication to receiving phototherapy such as malignancy, systemic lupus
- •Dermoscopic evaluation revealing absence of any signs of presence of hair follicles.
- •Any psychiatric illness or psychological state impairing future compliance or influencing expectations of the patient.
- •Patients with AA totalis or Ophiasis
研究组 & 干预措施
Phototherapeutic
0.5% solution of 8-methoxypsoralen (MOP) will be applied 20 minutes before UVA exposure (315-400nm).
UVA sessions will be carried out twice weekly aiming to achieve a phototoxic reaction, in the form of erythema and vesiculation. Once a phototoxic reaction will be achieved, the patient will be asked to rest until the reaction subsides and then resume the phototherapy sessions.
干预措施: ultraviolet A (UVA) (Radiation)
Conventional therapy
One monthly injections of intralesional potent corticosteroids
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Treatment success
时间窗: After six months from onset of treatment
Treatment success defined as effective sustained growth of hair in more than 80% of the affected area at the EOS. Clinical assessment will be performed by one non-blinded, and two blinded investigators.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(After six months from onset of treatment)
- Tissue cytokines response to therapy(At early hair regrowth, but no later than three months of treatment onset, in case of failed hair regrowth)
研究者
Hoda Mohamed Rasheed
Professor
Cairo University