Comparison of Topical Calcipotriol and Intralesional Steroids in Alopecia Areata

Official title

Comparison of Topical Calcipotriol Versus Intralesional Corticosteroids in the Treatment of Alopecia Areata: A Randomized Controlled Trial

Overview

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.

Detailed description

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.

Treatment duration was 12 weeks with follow-up assessments at weeks 4, 8, and 12.

The primary outcome measure was change in Severity of Alopecia Tool (SALT) score from baseline to week 12. Secondary outcomes included percentage improvement in SALT score, proportion of participants achieving predefined treatment efficacy, and recording of adverse events.

Data were analyzed using Statistical Package for Social Sciences (SPSS) version 25. Continuous variables were expressed as mean ± standard deviation, and categorical variables were presented as frequencies and percentages. Between-group comparisons were performed using independent t-tests and chi-square tests as appropriate, with a significance level set at p \< 0.05.

Interventions

• Drug Calcipotriol
  Topical calcipotriol 0.005% ointment was applied to affected scalp areas twice daily for 12 weeks. Participants were instructed to apply a thin layer over alopecia patches and gently massage into the scalp. Treatment response was evaluated at weeks 4, 8, and 12 using the Severity of Alopecia Tool (SALT) score. Adverse effects were monitored throughout the study period
• Drug Triamcinolone Acetonide
  Triamcinolone acetonide was administered as intralesional injections at a concentration of 5 mg/mL into alopecia patches at 4-week intervals for 12 weeks. Injections were delivered intradermally using a fine-gauge needle, with dose distributed across affected lesions according to lesion size. Clinical response was assessed at weeks 4, 8, and 12 using the Severity of Alopecia Tool (SALT) score. Participants were monitored for local adverse effects such as skin atrophy and telangiectasia.

Primary outcome measures

• Change in Severity of Alopecia Tool (SALT) Score From Baseline to Week 12 [Time frame: Baseline to Week 12]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Alam M, Amin SS, Adil M, Arif T, Zahra FT, Varshney I. Comparative Study of Efficacy of Topical Mometasone with Calcipotriol versus Mometasone Alone in the Treatment of Alopecia Areata. Int J Trichology. 2019 May-Jun;11(3):123-127. doi: 10.4103/ijt.ijt_18_19. PMID 31360041
• Lee S, Lee WS. Management of alopecia areata: Updates and algorithmic approach. J Dermatol. 2017 Nov;44(11):1199-1211. doi: 10.1111/1346-8138.13933. Epub 2017 Jun 21. PMID 28635045
• Strazzulla LC, Wang EHC, Avila L, Lo Sicco K, Brinster N, Christiano AM, Shapiro J. Alopecia areata: Disease characteristics, clinical evaluation, and new perspectives on pathogenesis. J Am Acad Dermatol. 2018 Jan;78(1):1-12. doi: 10.1016/j.jaad.2017.04.1141. PMID 29241771
• Molinelli E, Campanati A, Brisigotti V, Sapigni C, Paolinelli M, Offidani A. Efficacy and Safety of Topical Calcipotriol 0.005% Versus Topical Clobetasol 0.05% in the Management of Alopecia Areata: An Intrasubject Pilot Study. Dermatol Ther (Heidelb). 2020 Jun;10(3):515-521. doi: 10.1007/s13555-020-00379-7. Epub 2020 Apr 27. PMID 32342443

Identifiers

NCT: NCT07453238 · AA-RCT-2026-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗