Hypertrichosis Clinical Trial
Official title:
Gender Affirmative Treatment of Hypertrichosis With Intense Pulsed Light - Effect on Hair Reduction and Quality of Life
NCT number | NCT05775328 |
Other study ID # | 2023-0222-01 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2023 |
Est. completion date | July 1, 2026 |
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.
Status | Recruiting |
Enrollment | 39 |
Est. completion date | July 1, 2026 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Norrlands University Hospital | Umeå | Västerbotten |
Lead Sponsor | Collaborator |
---|---|
Alexander Shayesteh |
Sweden,
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. — View Citation
Cheewadhanaraks S, Peeyananjarassri K, Choksuchat C. Clinical diagnosis of hirsutism in Thai women. J Med Assoc Thai. 2004 May;87(5):459-63. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: Hum Reprod Update. 2013 Mar-Apr;19(2):207. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Saleh D, Yarrarapu SNS, Cook C. Hypertrichosis. 2023 Aug 16. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK534854/ — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Complications | Side-effects such as pigmentation disturbances, blisters or skin shedding post-treatment. These complications will be assessed and descriptively reported. | 2023-2025 |
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