Comparison of Topical Calcipotriol and Intralesional Steroids in Alopecia Areata

NCT07453238 | Not Yet Recruiting Phase 4

• 1 other identifier: AA-RCT-2026-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alopecia Areata

Keywords

Alopecia Areata; Topical Calcipotriol; Intralesional Corticosteroids; Randomized Controlled Trial; Hair Regrowth; Vitamin D Analog; Patchy Alopecia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Topical Calcipotriol

EXPERIMENTAL

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

Intralesional Corticosteroids

ACTIVE COMPARATOR

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

Interventions

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

Topical Calcipotriol

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.

Intralesional Corticosteroids

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Related Publications (4)

• 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.

  RESULT

• Lee S, Lee W. Management of alopecia areata: Updates and algorithmic approach. The Journal of Dermatology. 2017 Nov;44(11):1199-211.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Alopecia Areata; Diffuse alopecia

Interventions

calcipotriene; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Huma Gul Huma Gul, FCPS

CONTACT

03319061411; gul.gullaii.1995@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGR

Model Details: This is a single-center, parallel-group, randomized controlled trial with two arms in a 1:1 allocation ratio. Participants were randomly assigned to receive either topical calcipotriol or intralesional corticosteroid injections for 12 weeks. Outcomes were assessed at 4-week intervals using the Severity of Alopecia Tool (SALT) score.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share