Comparison of Topical Calcipotriol and Intralesional Steroids in Alopecia Areata (CALISTA-AA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Calcipotriol; Drug: Triamcinolone Acetonide

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Huma Gul Huma Gul, FCPS; Phone Number: 03319061411; Email: gul.gullaii.1995@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Severity of Alopecia Tool (SALT) Score From 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.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Hayat Abad Medical Complex, Peshawar

Publications and helpful links

General Publications

• Alam M, Amin S, Adil M, Arif T, Zahra F, Varshney I. Comparative study of efficacy of topical mometasone with calcipotriol versus mometasone alone in the treatment of alopecia areata. Int J Trichol. 2019;11(3):123.
• Lee S, Lee W. Management of alopecia areata: Updates and algorithmic approach. The Journal of Dermatology. 2017 Nov;44(11):1199-211.
• Strazzulla LC, Wang EHC, Avila L, Lo Sicco K, Brinster N, Christiano AM, et al. Alopecia areata. Journal of the American Academy of Dermatology. 2018 Jan;78(1):1-12.
• 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):515-21.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Alopecia Areata; Hair Regrowth; Topical Calcipotriol; Intralesional Corticosteroids; Vitamin D Analog; Patchy Alopecia
• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata; Diffuse alopecia; Polycyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Triamcinolone Acetonide; calcipotriene
• Other Study ID Numbers: AA-RCT-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to institutional policy and confidentiality considerations. The dataset contains sensitive patient information, and no formal data-sharing agreement or repository mechanism has been established for this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No