Excimer Light and Topical Steroid in Treatment of Alopecia Areata

NCT04793945 | Unknown Phase 4

• 1 other identifier: fmztaraaf
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Alopecia areata is a polygenic autoimmune disease causing hair loss, particularly during the anagen phase of hair growth This condition has a lifetime risk of about 2.1% of the world population and the cumulative incidence seems to rise linearly with age . Patchy non scarring hair loss on the scalp is the most common clinical presentation, although it can also occur elsewhere . In addition to patchy Alopecia Areata , a more severe form, alopecia totalis , presents with diffuse hair loss across the scalp. In the most severe form, alopecia universalis , hair loss occurs on all areas of the body, including the beard, eyelashes, and extremities .

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (8)

• Severity of ALopecia Tool score

  The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40 percent (0.40), right side = 18 percent (0.18), left side = 18 percent (0.18) and the posterior aspect = 24 percent (0.24). Percentage of hair loss in any of the four areas was multiplied by the percentage of the scalp covered in that area. The Severity of Alopecia Tool score is the sum of the percentage of hair loss in all the areas mentioned above.\[10\]

  9months

• digital photographs

  using identical camera settings, lighting, patient positioning and background.

  9months

• The hair regrowth in the patches of alopecia

  0 = no hair regrowth, 1. = 1-25percent hair regrowth, 2. = 26-50percent hair regrowth, 3. = 51-75percent hair regrowth, and 4. = 76-100 percent hair regrowth.

  9months

• Dermoscopic evaluation

  Dermoscopy will be used to analyze the change in the count of hair at intervals of 4 weeks. The number of hair (total, vellus, and terminal hairs) will be calculated by dermoscopy .

  9months

• A patient satisfaction score

  0 to 25percent change = not satisfied, 26 to 50percent = mildly satisfied, 51 to 75percent = moderately satisfied, 76 to 100percent = very satisfied

  9months

• adverse effects

  Any encountered adverse effects in terms of pain, erythema, edema and crusts will be recorded.

  9months

• dermoscopic evaluation

  The mean diameter of hair will be recorded for analysis.

  9months

• dermoscopic evaluation

  diameter of hair will be measured

  9months

Study Arms (2)

light therapy twice weekly

ACTIVE COMPARATOR

15 or half of the patients with three patches of Alopecia Areata on the scalp the first patch will be treated by 308nm Excimer light twice weekly and topical steroid twice daily the second patch will be treated by topical steroid twice daily. the third patch will be left as a control.

Combination Product: topical steroid and 308nm-Excimer light therapy

light therapy once weekly

ACTIVE COMPARATOR

15 or half of the patients with three patches of Alopecia Areata on the scalp the first patch will be treated by 308nm Excimer light once weekly and topical steroid twice daily. the second patch will be treated by topical steroid twice daily. the third patch will be left as a control.

Combination Product: topical steroid and 308nm-Excimer light therapy

Interventions

topical steroid and 308nm-Excimer light therapy COMBINATION_PRODUCT

applying topical steroid in combination with 308nm-Excimer light therapy to treat Alopecia Areata

light therapy once weekly; light therapy twice weekly

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 16-40 years,
• Good general health,
• A clinical diagnosis of multiple Alopecia Areata of the scalp.
• Hair loss \<25 percent of the total scalp.
• No use of drugs or hair care products influencing hair growth in the last 2 months.

You may not qualify if:

• Other causes of hair loss (like endocrine or immunological diseases).
• Skin disease in the treatment area.
• Pregnant or lactating patients.
• Hair transplantation history.
• Photosensitivity history.
• Malignant tumor history.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (24)

• Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11.

  PMID: 28300084 BACKGROUND

• Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014 Apr;134(4):1141-1142. doi: 10.1038/jid.2013.464. Epub 2013 Nov 11. No abstract available.

  PMID: 24202232 BACKGROUND

• Villasante Fricke AC, Miteva M. Epidemiology and burden of alopecia areata: a systematic review. Clin Cosmet Investig Dermatol. 2015 Jul 24;8:397-403. doi: 10.2147/CCID.S53985. eCollection 2015.

  PMID: 26244028 BACKGROUND

• Hordinsky MK. Overview of alopecia areata. J Investig Dermatol Symp Proc. 2013 Dec;16(1):S13-5. doi: 10.1038/jidsymp.2013.4.

  PMID: 24326541 BACKGROUND

• Girman CJ, Hartmaier S, Roberts J, Bergfeld W, Waldstreicher J. Patient-perceived importance of negative effects of androgenetic alopecia in women. J Womens Health Gend Based Med. 1999 Oct;8(8):1091-5. doi: 10.1089/jwh.1.1999.8.1091.

  PMID: 10565667 BACKGROUND

• Wells PA, Willmoth T, Russell RJ. Does fortune favour the bald? Psychological correlates of hair loss in males. Br J Psychol. 1995 Aug;86 ( Pt 3):337-44. doi: 10.1111/j.2044-8295.1995.tb02756.x.

  PMID: 7551645 BACKGROUND

• Al Hamzawi NK. Evaluation of the Efficacy and Safety of 308-nm Monochromatic Excimer Lamp in the Treatment of Resistant Alopecia Areata. Int J Trichology. 2019 Sep-Oct;11(5):199-206. doi: 10.4103/ijt.ijt_74_19.

  PMID: 31728102 BACKGROUND

• McElwee KJ, Gilhar A, Tobin DJ, Ramot Y, Sundberg JP, Nakamura M, Bertolini M, Inui S, Tokura Y, King LE Jr, Duque-Estrada B, Tosti A, Keren A, Itami S, Shoenfeld Y, Zlotogorski A, Paus R. What causes alopecia areata? Exp Dermatol. 2013 Sep;22(9):609-26. doi: 10.1111/exd.12209.

  PMID: 23947678 BACKGROUND

• Olsen EA, Hordinsky MK, Price VH, Roberts JL, Shapiro J, Canfield D, Duvic M, King LE Jr, McMichael AJ, Randall VA, Turner ML, Sperling L, Whiting DA, Norris D; National Alopecia Areata Foundation. Alopecia areata investigational assessment guidelines--Part II. National Alopecia Areata Foundation. J Am Acad Dermatol. 2004 Sep;51(3):440-7. doi: 10.1016/j.jaad.2003.09.032. No abstract available.

  PMID: 15337988 BACKGROUND

• Messenger AG, McKillop J, Farrant P, McDonagh AJ, Sladden M. British Association of Dermatologists' guidelines for the management of alopecia areata 2012. Br J Dermatol. 2012 May;166(5):916-26. doi: 10.1111/j.1365-2133.2012.10955.x. No abstract available.

  PMID: 22524397 BACKGROUND

• 12. Kranseler, J. S. & Sidbury, R. 2017. Alopecia Areata: Update on Management. Indian Journal of Paediatric Dermatology, 18, 261.

  BACKGROUND

• Charuwichitratana S, Wattanakrai P, Tanrattanakorn S. Randomized double-blind placebo-controlled trial in the treatment of alopecia areata with 0.25% desoximetasone cream. Arch Dermatol. 2000 Oct;136(10):1276-7. doi: 10.1001/archderm.136.10.1276. No abstract available.

  PMID: 11030789 BACKGROUND

• Kubeyinje EP. Intralesional triamcinolone acetonide in alopecia areata amongst 62 Saudi Arabs. East Afr Med J. 1994 Oct;71(10):674-5.

  PMID: 7821250 BACKGROUND

• Samrao A, Fu JM, Harris ST, Price VH. Bone mineral density in patients with alopecia areata treated with long-term intralesional corticosteroids. J Drugs Dermatol. 2013 Feb;12(2):e36-40.

  PMID: 23377403 BACKGROUND

• Herz-Ruelas ME, Welsh O, Gomez-Flores M, Welsh E, Miranda-Maldonado I, Ocampo-Candiani J. Ultraviolet A-1 phototherapy as an alternative for resistant alopecia areata. Int J Dermatol. 2015 Oct;54(10):e445-7. doi: 10.1111/ijd.13054. No abstract available.

  PMID: 26394604 BACKGROUND

• El Taieb MA, Hegazy EM, Ibrahim HM, Osman AB, Abualhamd M. Topical calcipotriol vs narrowband ultraviolet B in treatment of alopecia areata: a randomized-controlled trial. Arch Dermatol Res. 2019 Oct;311(8):629-636. doi: 10.1007/s00403-019-01943-8. Epub 2019 Jun 24.

  PMID: 31236672 BACKGROUND

• Darwin E, Arora H, Hirt PA, Wikramanayake TC, Jimenez JJ. A review of monochromatic light devices for the treatment of alopecia areata. Lasers Med Sci. 2018 Feb;33(2):435-444. doi: 10.1007/s10103-017-2412-6. Epub 2017 Dec 17.

  PMID: 29250710 BACKGROUND

• Panchaprateep R, Pisitkun T, Kalpongnukul N. Quantitative proteomic analysis of dermal papilla from male androgenetic alopecia comparing before and after treatment with low-level laser therapy. Lasers Surg Med. 2019 Sep;51(7):600-608. doi: 10.1002/lsm.23074. Epub 2019 Mar 7.

  PMID: 30843235 BACKGROUND

• Esmat SM, Hegazy RA, Gawdat HI, Abdel Hay RM, Allam RS, El Naggar R, Moneib H. Low level light-minoxidil 5% combination versus either therapeutic modality alone in management of female patterned hair loss: A randomized controlled study. Lasers Surg Med. 2017 Nov;49(9):835-843. doi: 10.1002/lsm.22684. Epub 2017 May 10.

  PMID: 28489273 BACKGROUND

• Al-Dhalimi MA, Al-Janabi MH, Abd Al Hussein RA. The Use of a 1,540 nm Fractional Erbium-Glass Laser in Treatment of Alopecia Areata. Lasers Surg Med. 2019 Dec;51(10):859-865. doi: 10.1002/lsm.23133. Epub 2019 Jul 18.

  PMID: 31321800 BACKGROUND

• Cho SB, Goo BL, Zheng Z, Yoo KH, Kang JS, Kim H. Therapeutic efficacy and safety of a 1927-nm fractionated thulium laser on pattern hair loss: an evaluator-blinded, split-scalp study. Lasers Med Sci. 2018 May;33(4):851-859. doi: 10.1007/s10103-018-2437-5. Epub 2018 Jan 16.

  PMID: 29340854 BACKGROUND

• Majid I, Jeelani S, Imran S. Fractional Carbon Dioxide Laser in Combination with Topical Corticosteroid Application in Resistant Alopecia Areata: A Case Series. J Cutan Aesthet Surg. 2018 Oct-Dec;11(4):217-221. doi: 10.4103/JCAS.JCAS_96_18.

  PMID: 30886476 BACKGROUND

• McMichael AJ. Excimer laser: a module of the alopecia areata common protocol. J Investig Dermatol Symp Proc. 2013 Dec;16(1):S77-9. doi: 10.1038/jidsymp.2013.31.

  PMID: 24326569 BACKGROUND

• Li A, Meng X, Xing X, Tan H, Liu J, Li C. Efficacy and Influence Factors of 308-nm Excimer Lamp with Minoxidil in the Treatment of Alopecia Areata. Lasers Surg Med. 2020 Oct;52(8):761-767. doi: 10.1002/lsm.23210. Epub 2020 Jan 9.

  PMID: 31919885 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Interventions

Steroids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Fatma m zidan, student

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

eman R mohamed hofny, professor

CONTACT

01005298992; e_riad@yahoo.com

yasmeen M tawfik mhany, PHD

CONTACT

01006033331; dr.yasminmostawfik@yahoo.com

Study Design

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

Model Details: patients with three patches of Alopecia Areata the first patch will be treated by topical steroid and Excimer light the second patch will be treated by topical steroid only the third patch will be left as a control

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 11, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: September 30, 2022
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: one year