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NCT Number: NCT07453238

Comparison of Topical Calcipotriol and Intralesional Steroids in Alopecia Areata

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcipotriol

Drug

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

Triamcinolone Acetonide

Drug

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 outcomes

  1. Change in Severity of Alopecia Tool (SALT) Score From Baseline to Week 12

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huma Gul Huma Gul, FCPS

CONTACT

[email protected]

03319061411

Sponsors and collaborators

Lead sponsor

Hayat Abad Medical Complex, Peshawar

Other Gov

Registry information

Official study title

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

Acronym: CALISTA-AA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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