Excimer Light and Topical Steroid in Treatment of Alopecia Areata

NCT ID: NCT04793945

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Alopecia Areata can have a large impact on patients' quality of life, causing both cosmetic and psychosocial distress. Studies on the impact of hair loss have shown high levels of self-consciousness, jealousy, embarrassment, depression, introversion, and decreased self-esteem .

Alopecia Areata can occur at any age, but it is most common among young and middle-aged people . Both sexes are equally affected. Several environmental factors have been suggested as triggering Alopecia Areata, including infection, drugs, trauma, and stress. Thyroid autoimmune disease, atopy, and vitiligo are commonly associated. Diverse physical or psychological insults may trigger the episodes of Alopecia Areata, but there is no evidence that they influence prognosis.

Etiology of Alopecia Areata is not completely understood, and the majority of evidence suggests that genetically predisposed individuals, when exposed to an unknown trigger, develop a predominantly autoimmune reaction, leading to acute hair loss.

Although many patients improve spontaneously or respond to standard therapy, treatment can be quite challenging in those with more severe and refractory disease .

Topical corticosteroids are often the first line of treatment for mild patchy alopecia, with the underlying mechanism being containment of inflammation and hastening of the recovery of damaged hair follicles . Additionally, corticosteroids may be delivered via intralesional injection with slightly better effects (63% with complete regrowth within 4 months in one study . However, this method cannot be used for rapidly progressing variants and does not prevent hair loss at other sites . Furthermore, both topical and intralesional steroids increase the risk of cutaneous atrophy at the site of treatment, and intralesional steroids may decrease bone mineral density .

With the development of new technologies, more and more lasers or lamps have been used to treat alopecia, such as ultraviolet , Excimer laser/lamp , low-level laser , erbium-glass laser, thulium laser , and carbon dioxide laser . Individual researchers have been considering 308-nm Excimer lamp to be used for treating Alopecia Areata by inducing apoptosis of T lymphocytes, but the effective rates had differences in studies .

Excimer laser using high-dose monochromatic UV radiation can trigger apoptosis and induce immunological suppression through altering cytokine production such as interleukin-4, interleukin-10, prostaglandin E2, platelet-activating factor, and cis-urocanic acid .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alopecia Areata

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

light therapy twice weekly

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.

Group Type ACTIVE_COMPARATOR

topical steroid and 308nm-Excimer light therapy

Intervention Type COMBINATION_PRODUCT

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

light therapy once weekly

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.

Group Type ACTIVE_COMPARATOR

topical steroid and 308nm-Excimer light therapy

Intervention Type COMBINATION_PRODUCT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

topical steroid and 308nm-Excimer light therapy

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

fatma magdy zidan taraaf

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fatma m zidan, student

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

eman R mohamed hofny, professor

Role: CONTACT

01005298992 ext. 002

yasmeen M tawfik mhany, PHD

Role: CONTACT

01006033331 ext. 002

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28300084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24202232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26244028 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 24326541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10565667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7551645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31728102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23947678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15337988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22524397 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 11030789 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 7821250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23377403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26394604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31236672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29250710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30843235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28489273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31321800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29340854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30886476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24326569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31919885 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

fmztaraaf

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Excimer Light for Alopecia Areata
NCT01802177 UNKNOWN PHASE2
New Treatment of Alopecia Areata
NCT05594316 COMPLETED NA
Stem Cell Educator Therapy in Alopecia Areata
NCT01673789 UNKNOWN PHASE1/PHASE2