Alopecia AreataPhase 4CALISTA-AANCT07453238
Comparison of Topical Calcipotriol and Intralesional Steroids in Alopecia Areata
A Phase 4 study testing Calcipotriol and Triamcinolone Acetonide in people with Alopecia Areata, run by Hayat Abad Medical Complex, Peshawar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Calcipotriol and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Mar 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alopecia Areata
- Being tested
- Calcipotriol, Triamcinolone Acetonide
- Keywords
- Alopecia Areata, Topical Calcipotriol, Intralesional Corticosteroids, Randomized Controlled Trial, Hair Regrowth, Vitamin D Analog, Patchy Alopecia
- Medical subject headings
- Alopecia Areata, Diffuse alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcipotriolDrug
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 AcetonideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huma Gul, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453238
- Sponsor's protocol ID
- AA-RCT-2026-01
- Acronym
- CALISTA-AA
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 31360041Lee 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.
PubMed 28635045Strazzulla 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.
PubMed 29241771Molinelli 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.
PubMed 32342443