Advertisement

Cyclosporine for moderate-to-severe alopecia areata: A double-blind, randomized, placebo-controlled clinical trial of efficacy and safety

Published:April 29, 2019DOI:https://doi.org/10.1016/j.jaad.2019.04.053

      Background

      Despite widespread use of steroid-sparing agents, particularly cyclosporine, for treatment of alopecia areata (AA), there are no clinical trials investigating the efficacy of these agents.

      Objective

      To evaluate the efficacy of cyclosporine compared with placebo at 3 months in patients aged 18 to 65 years with moderate-to-severe AA.

      Methods

      A double-blind, randomized, placebo-controlled trial was conducted. Adults aged 18 to 65 years of age with moderate-to-severe AA were randomized in a 1:1 ratio to receive 3 months of cyclosporine (4 mg/kg/d) or matching placebo. Blinded assessments included physical examination, blood biochemistry, photography, quality of life measurements, and efficacy evaluation using Severity of Alopecia Tool score and eyelash and eyebrow assessment scales.

      Results

      The results obtained for 32 participants (16 who received cyclosporine and 16 who received placebo) were analyzed. Compared with the placebo group, the cyclosporine group had a greater proportion of participants achieving at least a 50% reduction in Severity of Alopecia Tool score (31.3% vs 6.3% [P = .07]) and greater proportion of participants achieving a 1-grade improvement in eyelash (18.8% vs 0% [P = .07]) and eyebrow (31.3% vs 0% [P = .02]) scale score.

      Limitations

      Small sample size and single-institution trial may limit interpretation and generalizability of these results.

      Conclusion

      Response approached but did not reach a statistically significant difference between cyclosporine and placebo.

      Key words

      Abbreviations used:

      AA (alopecia areata), AT (alopecia totalis), AU (alopecia universalis), QOL (quality of life), SALT (Severity of Alopecia Tool)
      To read this article in full you will need to make a payment
      AAD Member Login
      AAD Members, full access to the journal is a member benefit. Use your society credentials to access all journal content and features
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Purchase one-time access:

      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Cooper G.S.
        • Bynum M.L.K.
        • Somers E.C.
        Recent insights in the epidemiology of autoimmune diseases: improved prevalence estimates and understanding of clustering of diseases.
        J Autoimmun. 2009; 33: 197-207
        • Le Cleach L.
        • Chosidow O.
        Clinical practice. Lichen planus.
        N Engl J Med. 2012; 366: 723-732
        • Safavi K.H.
        • Muller S.A.
        • Suman V.J.
        • Moshell A.N.
        • Melton 3rd, L.J.
        Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989.
        Mayo Clinic Proc. 1995; 70: 628-633
      1. Cranwell WC, Lai VW, Photiou L, Meah N, Wall D, Rathnayake D, et al, Treatment of alopecia areata: an Australian expert consensus statement. Australas J Dermatol. https://doi.org/10.1111/ajd.12941. Accessed October 24, 2018.

        • Lai V.W.
        • Chen G.
        • Gin D.
        • Sinclair R.
        Systemic treatments for alopecia areata: a systematic review.
        Australas J Dermatol. 2019; 60: e1-e13
        • Acikgoz G.
        • Caliskan E.
        • Tunca M.
        • Yeniay Y.
        • Akar A.
        The effect of oral cyclosporine in the treatment of severe alopecia areata.
        Cutan Ocul Toxicol. 2014; 33: 247-252
        • Gupta A.K.
        • Ellis C.N.
        • Cooper K.D.
        • et al.
        Oral cyclosporine for the treatment of alopecia areata. A clinical and immunohistochemical analysis.
        J Am Acad Dermatol. 1990; 22: 242-250
        • Ferrando J.
        • Grimalt R.
        Partial response of severe alopecia areata to cyclosporine A.
        Dermatology. 1999; 199: 67-69
        • Jang Y.H.
        • Kim S.L.
        • Lee K.C.
        • et al.
        A comparative study of oral cyclosporine and betamethasone minipulse therapy in the treatment of alopecia areata.
        Ann Dermatol. 2016; 28: 569-574
        • Mendoza T.R.
        • Osei J.S.
        • Shi Q.
        • Duvic M.
        Development of the alopecia areata symptom impact scale.
        J Investig Dermatol Symp Proc. 2013; 16: S51-S52
        • Richardson J.
        • Iezzi A.
        • Khan M.A.
        • Maxwell A.
        Validity and reliability of the Assessment of Quality of Life (AQoL)-8D multi-attribute utility instrument.
        Patient. 2014; 7: 85-96
        • Price V.
        Double-blind, placebo-controlled evaluation of topical minoxidil in extensive alopecia areata.
        J Am Acad Dermatol. 1987; 16: 730-736
        • StataCorp
        Stata Statistical Software: release 12.
        StataCorp LP, College Station, TX2011
        • Chiang K.S.
        • Mesinkovska N.A.
        • Piliang M.P.
        • Bergfeld W.F.
        Clinical efficacy of diphenylcyclopropenone in alopecia areata: retrospective data analysis of 50 patients.
        J Investig Dermatol Symp Proc. 2015; 17: 50-55
      2. Peeva E, Craiglow B, Banerjee A, et al. A phase 2a randomized, placebo-controlled study to evaluate efficacy and safety of Janus kinase inhibitors PF-06651600 and PF-06700841 in alopecia areata: 24-week results. Abstract presented at the 27th European Academy of Dermatology and Venereology Congress. September 12-16, 2018; Paris, France.