Therapeutic evaluation of a topical unani formulation in the treatment of Hazaz (Pityriasis capitis): A randomizes open label pilot controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adherent scalp flaking score (ASFS)
研究概览
简要总结
Huzaz (pityriasis capitis) also known as dandruff is a prevalant scalp disorder affecting more than half of world adult population. it is considered the mildest from of seborreic dermatitis involving subclinicaal inflammation. in comparison seborreic dermatitis exihibits a more inflammatroy nature on the scalp. Pityriasis capitis is characterized by increased scalp epidermal proliferation, along with itching and redness. It shows varying levels of severity and is more common in men than women. The condition is most frequently observed in adolescents aged 15-24 years and in older adults above 50 years[4]. The causative organism of pityriasis capitis is Malassezia globosa, a yeast-like fungus that feeds on scalp, feeding on skin oils. Treatment option for dandruff icluding ointment lotions and shampoo. such as zinc pyrithione, salicylic acid, imidazole derivatives, selenium sulfide, tar derivatives, and ketoconazole. However, these synthetic agents are reported to cause side effects like hair loss, increased scaling, itching, nausea, headache, vomiting, photosensitivity, and even cancer. this highlight the need for expooring alternative treatment modakities, where uanani medicine could play a crucial role in providing aq safe and effective treatment. considering all the factors the present study has been desingned to assess the safty and efficacay of a topical unani formulation cosisting of ab-i chuqandar mixed bura armani in managing hazaz comared to ketoconazole 2%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Patients of age group of 15 to 65 years with a clinical diagnosis of adherent dandruff of the scalp.
- •2 Must have active adherent dandruff of the scalp 3 Investigators global assessment (IGA) for pruritis score of at least
- •4 Understand and willing to sign written informed consent in case of adults and written parental assent in case of children wherever applicable.
排除标准
- •1 Pregnant or lactating women by history.
- •2 History of overt bacterial, viral or fungal infection of the head/neck 3 Patients with history or presence of any serious disease including immunological conditions like HIV, current malignancies, diabetes mellitus.
- •Hypertension, etc.
- •4History or presence of compromising dermatosis elsewhere on the skin; 5 Patients with damaged skin of scalp 6 Patients with any skin condition e.g., psoriasis, acne, atopic dermatitis; 7 Patients who had used within 1 month prior to baseline any topical and systemic treatment for scalp diseases.
结局指标
主要结局
Adherent scalp flaking score (ASFS)
时间窗: Baseline 5th day 9th day and 14th day
次要结局
- 1 IGA for pruritus on 4 point scale(2 Dermatology life quality index (DLQI))
