Treatment of Hypertrichosis With Intense Pulsed Light

NCT05775328 | Recruiting

• 1 other identifier: 2023-0222-01
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational cohort study is to investigate the effect of intense pulsed light (IPL) for excessive hair in patients \>18 years of age and in need of gender affirmative treatment, refered to the department of dermatology and venereology, Umeå University Hospital, Sweden. The main questions this study aims to answer are:

• \[To evaluate the effect of consecutive IPL treatments in women with hirsutism due to polycystic ovarial syndrome (PCOS), with or without anti-androgen treatment\]
• \[To evaluate the effect of consecutive IPL treatments in individuals born as biologically men but in transition to become women, with or without hormonal treatment\]. Patients will use self-assessed questionnaires evaluating:
• Background characteristics and time spend on concealing, reducing and treating hypertrichosis at home.
• Ferriman-Gallwey scale, regarding the intensity of their hypertrichosis.
• Dermatology Life Quality Index (DLQI) for quality of life Patients will be recruited consecutively and assessed at each visit, at the clinic before the treatments, ranging from baseline to a minimum of 5 treatment sessions.Since this is an observational study, all patients are treated by others than the researchers according to the routines och the clonic and there will be no other groups to compare the patients with.

Conditions

Hypertrichosis; Hirsutism - Hypertrichosis

Keywords

Hypertrichosis; Hirsutism; Hair reduction; Quality of Life

Outcome Measures

Primary Outcomes (1)

• DLQI

  The scale of Dermatology Life Quality Index. Anticipated reduction by 3 mean points between basle-line and the last treatment session.

  2023-2025

Secondary Outcomes (1)

• Complications

  2023-2025

Study Arms (1)

Patients with hypertrichosis

Patients suffering from hypertrichosis or hirsutism according to Ferriman-Galway scale criteria and treated with intense pulse light for a total of 5 sessions.

Other: Intense pulsed light

Interventions

Intense pulsed light OTHER

Already described in the arm/group description

Patients with hypertrichosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hirsutism and gender dysphoria are medically treated and have their follow-ups by other specialities than dermatology. However, the laser clinic at the department of Dermatology and Venereology, Umeå university hospital receives referrals from other healthcare departments, across northern Sweden, for body hair reduction. Consecutive patients referred to the department of dermatology and venereology at Umeå University Hospital due to hypertrichosis will be assessed according to our inclusion and exclusion criteria.

You may qualify if:

• years of age and above
• Diagnosis of PCOS obtained by a gynaecologist and hirsutism,
• Diagnosis of gender dysphoria obtained after psychiatric evaluation,
• ≥3 points in hair density according to Ferriman-Gallwey scale on a specific part of the body

You may not qualify if:

• Language barrier causing problem in understanding questionnaires or not being able to give consent
• Hair colours of white, orange or grey hair
• Skin type 5 and above according to Fitzpatrick
• Hereditary hypertrichosis

Sponsors & Collaborators

• Alexander Shayesteh: lead

Study Sites (1)

Norrlands University Hospital

Umeå, Västerbotten County, 90185, Sweden

RECRUITING

Related Publications (14)

• Park AM, Khan S, Rawnsley J. Hair Biology: Growth and Pigmentation. Facial Plast Surg Clin North Am. 2018 Nov;26(4):415-424. doi: 10.1016/j.fsc.2018.06.003. Epub 2018 Aug 16.

  PMID: 30213423 BACKGROUND

• Mimoto MS, Oyler JL, Davis AM. Evaluation and Treatment of Hirsutism in Premenopausal Women. JAMA. 2018 Apr 17;319(15):1613-1614. doi: 10.1001/jama.2018.2611.

  PMID: 29522641 BACKGROUND

• Saleh D, Yarrarapu SNS, Cook C. Hypertrichosis. 2023 Aug 16. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK534854/

  PMID: 30521275 BACKGROUND

• FERRIMAN D, GALLWEY JD. Clinical assessment of body hair growth in women. J Clin Endocrinol Metab. 1961 Nov;21:1440-7. doi: 10.1210/jcem-21-11-1440. No abstract available.

  PMID: 13892577 BACKGROUND

• DeUgarte CM, Woods KS, Bartolucci AA, Azziz R. Degree of facial and body terminal hair growth in unselected black and white women: toward a populational definition of hirsutism. J Clin Endocrinol Metab. 2006 Apr;91(4):1345-50. doi: 10.1210/jc.2004-2301. Epub 2006 Jan 31.

  PMID: 16449347 BACKGROUND

• Escobar-Morreale HF, Carmina E, Dewailly D, Gambineri A, Kelestimur F, Moghetti P, Pugeat M, Qiao J, Wijeyaratne CN, Witchel SF, Norman RJ. Epidemiology, diagnosis and management of hirsutism: a consensus statement by the Androgen Excess and Polycystic Ovary Syndrome Society. Hum Reprod Update. 2012 Mar-Apr;18(2):146-70. doi: 10.1093/humupd/dmr042. Epub 2011 Nov 6.

  PMID: 22064667 BACKGROUND

• Cheewadhanaraks S, Peeyananjarassri K, Choksuchat C. Clinical diagnosis of hirsutism in Thai women. J Med Assoc Thai. 2004 May;87(5):459-63.

  PMID: 15222512 BACKGROUND

• Lindholm A, Andersson L, Eliasson M, Bixo M, Sundstrom-Poromaa I. Prevalence of symptoms associated with polycystic ovary syndrome. Int J Gynaecol Obstet. 2008 Jul;102(1):39-43. doi: 10.1016/j.ijgo.2008.01.023. Epub 2008 Mar 5.

  PMID: 18321516 BACKGROUND

• Coffey S, Mason H. The effect of polycystic ovary syndrome on health-related quality of life. Gynecol Endocrinol. 2003 Oct;17(5):379-86. doi: 10.1080/09513590312331290268.

  PMID: 14710585 BACKGROUND

• Clayton WJ, Lipton M, Elford J, Rustin M, Sherr L. A randomized controlled trial of laser treatment among hirsute women with polycystic ovary syndrome. Br J Dermatol. 2005 May;152(5):986-92. doi: 10.1111/j.1365-2133.2005.06426.x.

  PMID: 15888157 BACKGROUND

• Meyer G, Boczek U, Bojunga J. Hormonal Gender Reassignment Treatment for Gender Dysphoria. Dtsch Arztebl Int. 2020 Oct 23;117(43):725-732. doi: 10.3238/arztebl.2020.0725.

  PMID: 33559593 BACKGROUND

• van Zuuren EJ, Fedorowicz Z, Carter B, Pandis N. Interventions for hirsutism (excluding laser and photoepilation therapy alone). Cochrane Database Syst Rev. 2015 Apr 28;2015(4):CD010334. doi: 10.1002/14651858.CD010334.pub2.

  PMID: 25918921 BACKGROUND

• Babilas P, Schreml S, Szeimies RM, Landthaler M. Intense pulsed light (IPL): a review. Lasers Surg Med. 2010 Feb;42(2):93-104. doi: 10.1002/lsm.20877.

  PMID: 20166155 BACKGROUND

• Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.

  PMID: 8033378 BACKGROUND

MeSH Terms

Conditions

Hypertrichosis; Hirsutism

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Åsa Nordlund, Chief

  Region Västerbotten

  STUDY DIRECTOR

Central Study Contacts

Alexander Shayesteh, MD., PhD

CONTACT

+46907852078; alexander.shayesteh@umu.se

Maja Af Klinteberg, MD.,PhD

CONTACT

+46907856889; maja.af.klinteberg@umu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor and senior consultant

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)