Comparison of Topical Calcipotriol Versus Intralesional Corticosteroids in the Treatment of Alopecia Areata: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change in Severity of Alopecia Tool (SALT) Score From Baseline to Week 12
研究概览
简要总结
This randomized controlled trial compares the effectiveness of topical calcipotriol and intralesional corticosteroids in the treatment of alopecia areata. Alopecia areata is an autoimmune condition that causes non-scarring hair loss and can significantly affect quality of life. Intralesional corticosteroids are commonly used as first-line therapy; however, response rates vary and treatment may be associated with discomfort and local adverse effects.
Sixty adult patients with patchy alopecia areata involving less than 50% of the scalp were randomly assigned to receive either topical calcipotriol or intralesional corticosteroid injections for 12 weeks. Participants were evaluated at four-week intervals. Treatment response was assessed using the Severity of Alopecia Tool (SALT) score and percentage improvement from baseline.
The primary objective is to compare reduction in SALT score between the two treatment groups. Secondary outcomes include overall treatment efficacy and safety. The findings aim to determine whether topical calcipotriol provides superior or comparable clinical benefit to intralesional corticosteroids in patients with alopecia areata.
详细描述
Alopecia areata is a T-cell-mediated autoimmune disorder characterized by patchy, non-scarring hair loss. Although intralesional corticosteroids remain a standard therapeutic option for localized disease, their efficacy may be inconsistent and repeated injections can cause pain, skin atrophy, and telangiectasia. Vitamin D analogs such as calcipotriol have immunomodulatory effects and may promote hair regrowth by influencing local immune responses and hair follicle cycling.
This study was designed as a single-center, parallel-group, randomized controlled trial conducted over six months at a tertiary care dermatology department. A total of 60 patients aged 18 to 50 years with clinically diagnosed patchy alopecia areata affecting less than 50% of the scalp were enrolled after informed consent. Participants who had received topical or systemic treatment for alopecia areata within the previous three months, had scarring alopecia, diffuse alopecia, systemic autoimmune disease, pregnancy, or known hypersensitivity to study medications were excluded.
Eligible participants were randomized in a 1:1 ratio using a computer-generated randomization table into two groups:
Group A: Topical calcipotriol applied to affected areas.
Group B: Intralesional corticosteroid injections administered into lesions.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 50 years
- •Clinically diagnosed patchy alopecia areata
- •Scalp involvement of less than 50% (SALT score <50%)
- •No topical or systemic treatment for alopecia areata within the previous 3 months
- •Willingness to provide written informed consent
排除标准
- •Diffuse alopecia areata or scarring alopecia
- •Presence of other autoimmune diseases or significant systemic illness
- •Known hypersensitivity to calcipotriol or corticosteroids
- •Pregnant or lactating women
- •Current use of immunosuppressive therapy
- •Unwillingness to participate or provide informed consent
研究组 & 干预措施
Topical Calcipotriol
Participants in this arm received topical calcipotriol applied to affected scalp areas for 12 weeks. Treatment response was assessed at 4-week intervals using the Severity of Alopecia Tool (SALT) score
干预措施: Calcipotriol (Drug)
Intralesional Corticosteroids
Participants in this arm received intralesional corticosteroid injections administered into alopecia lesions for 12 weeks. Clinical response was evaluated at 4-week intervals using the Severity of Alopecia Tool (SALT) score.
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Change in Severity of Alopecia Tool (SALT) Score From Baseline to Week 12
时间窗: Baseline to Week 12
The primary outcome is the change in Severity of Alopecia Tool (SALT) score from baseline to 12 weeks of treatment. The SALT score quantifies the percentage of scalp hair loss. A greater reduction in SALT score indicates improved hair regrowth and treatment efficacy.
次要结局
未报告次要终点
研究者
Huma Gul
PGR
Hayat Abad Medical Complex, Peshawar