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| Name | Class |
|---|---|
| Merz Aesthetics Inc. | INDUSTRY |
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The purpose of this study is to evaluate the effect of using a purified botulinum toxin (Xeomin®, Merz, USA), the same injectable used to improve face wrinkles, to treat a specific type of hair loss seen in men and women not associated with scarring or other internal disease called 'pattern hair loss'. This type of hair loss is medically called 'androgenic or androgenetic alopecia'. In men it is typically called 'male pattern baldness' whereas in women it is called 'female pattern baldness' and in both cases is hereditary meaning there will be a history of relatives that describe having the same condition.
Adult volunteers aged 22-55 years presenting with mild to moderate patterned hair loss will be screened for participation. Twenty subjects (10 males and 10 females) meeting the inclusion/exclusion criteria will be recruited to participate. Prior to any injections a global photograph documenting the patterned hair loss will be acquired for each individual utilizing the Canfield global camera system. Each subject will then undergo trichoscopy imaging within the defined treatment area using the Canfield HairMetrix® system. The imaged area is at a higher magnification capable of reliable measurements for hair density (count/cm2), hair shaft diameter, follicular units, among other measurements captured by the software. Individual balding scalps will be outlined and mapped to include up to 30 injection sites evenly distributed within the hair loss area.
At each site, 5 Units of Xeomin® will be injected with a maximum of 150 Units total per subject. This will be a single, one-time treatment session. Consequently, subjects will be contacted by phone or will be asked to come into the clinic for follow up according to a set schedule.
At each follow up visit (monthly) subjects will be asked to report any adverse events. Follow up visits at the clinic will also include photographic documentation, trichoscopy, and investigator and subject subjective reporting of treatment progress.
There will be a total of up to 3 injectors, 1 person taking photographs (including trichoscopy), and 1 investigator assessing treatment outcome.
During this 9 month-long study, subjects cannot utilize other hair loss treatments and must maintain their grooming routine which includes maintaining their hair style.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single treatment with Xeomin® (incobotulinumtoxin A) | Experimental | Individual balding scalps will be outlined and mapped to include up to 30 injection sites evenly distributed within the hair loss area. At each site, 5 Units of Xeomin® will be injected with a maximum of 150 Units total per subject. This will be a single, one-time treatment session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| incobotulinumtoxin A | Drug | Up to 150 units of incobotulinumtoxin A will be injected at up to 30 injection sites within the hair loss area |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in hair count per cm2 (number of hairs per follicular unit) | Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline hair count per cm2 will be compared to day 30, day 90, day 180 and day 270. | Day 30, Day 90, Day 180, and Day 270 |
| Changes from baseline in sum of hair width per cm2 (total scalp coverage) | Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline sum of hair width per cm2 will be compared to day 30, day 90, day 180 and day 270. | Day 30, Day 90, Day 180, and Day 270 |
| Changes from baseline in Terminal:Vellus ratio (number of terminal hairs for every one vellus hair). | Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline Terminal:Vellus ratio will be compared to day 30, day 90, day 180 and day 270. | Day 30, Day 90, Day 180, and Day 270 |
| Changes from baseline in Average hairs per follicular unit (average number of hairs within a hair follicle). | Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline average hairs per follicular unit will be compared to day 30, day 90, day 180 and day 270. | Day 30, Day 90, Day 180, and Day 270 |
| Changes from baseline in Average hair width (microns) (average thickness of hair in microns). | Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline average hair width (microns) will be compared to day 30, day 90, day 180 and day 270. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in balding scalp hair recovery assessed by study investigator | Hair recovery will be assessed by the study investigator on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 30 |
| Change from baseline in balding scalp hair recovery assessed by study investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZelSkin and Laser Specialists | Edina | Minnesota | 55424 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30394586 | Background | Russo PM, Fino E, Mancini C, Mazzetti M, Starace M, Piraccini BM. HrQoL in hair loss-affected patients with alopecia areata, androgenetic alopecia and telogen effluvium: the role of personality traits and psychosocial anxiety. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):608-611. doi: 10.1111/jdv.15327. Epub 2018 Dec 2. | |
| 10583042 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 19, 2025 | Sep 5, 2025 | 6 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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|
| Day 30, Day 90, Day 180, and Day 270 |
| Changes from baseline in Follicle count per cm2 (number of follicles per square centimeter). | Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline follicle count per cm2 will be compared to day 30, day 90, day 180 and day 270. | Day 30, Day 90, Day 180, and Day 270 |
| Mean Inter-follicular distance (mm) (mean distance between follicular units). | Trichoscopy equipped with Canfield HairMetrix® software system will be performed on the scalp of study participants. The baseline mean inter-follicular distance (mm) will be compared to day 30, day 90, day 180 and day 270. | Day 30, Day 90, Day 180, and Day 270 |
Hair recovery will be assessed by the study investigator on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. |
| Day 90 |
| Change from baseline in balding scalp hair recovery assessed by study investigator | Hair recovery will be assessed by the study investigator on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 180 |
| Change from baseline in balding scalp hair recovery assessed by study investigator | Hair recovery will be assessed by the study investigator on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 270 |
| Change from baseline in balding scalp hair recovery assessed by study participant | Hair recovery will be assessed by the study participant on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 30 |
| Change from baseline in balding scalp hair recovery assessed by study participant | Hair recovery will be assessed by the study participant on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 90 |
| Change from baseline in balding scalp hair recovery assessed by study participant | Hair recovery will be assessed by the study participant on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 180 |
| Change from baseline in balding scalp hair recovery assessed by study participant | Hair recovery will be assessed by the study participant on a 4- point scale, where 0 is poor and 3 is excellent. Photographic documentation will be utilized. | Day 270 |
| Cash TF. The psychosocial consequences of androgenetic alopecia: a review of the research literature. Br J Dermatol. 1999 Sep;141(3):398-405. doi: 10.1046/j.1365-2133.1999.03030.x. |
| 15818439 | Background | Bienova M, Kucerova R, Fiuraskova M, Hajduch M, Kolar Z. Androgenetic alopecia and current methods of treatment. Acta Dermatovenerol Alp Pannonica Adriat. 2005 Mar;14(1):5-8. |
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| 22440736 | Background | Garza LA, Liu Y, Yang Z, Alagesan B, Lawson JA, Norberg SM, Loy DE, Zhao T, Blatt HB, Stanton DC, Carrasco L, Ahluwalia G, Fischer SM, FitzGerald GA, Cotsarelis G. Prostaglandin D2 inhibits hair growth and is elevated in bald scalp of men with androgenetic alopecia. Sci Transl Med. 2012 Mar 21;4(126):126ra34. doi: 10.1126/scitranslmed.3003122. |
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| 14819896 | Background | HAMILTON JB. Patterned loss of hair in man; types and incidence. Ann N Y Acad Sci. 1951 Mar;53(3):708-28. doi: 10.1111/j.1749-6632.1951.tb31971.x. No abstract available. |
| 1188424 | Background | Norwood OT. Male pattern baldness: classification and incidence. South Med J. 1975 Nov;68(11):1359-65. doi: 10.1097/00007611-197511000-00009. |
| 921894 | Background | Ludwig E. Classification of the types of androgenetic alopecia (common baldness) occurring in the female sex. Br J Dermatol. 1977 Sep;97(3):247-54. doi: 10.1111/j.1365-2133.1977.tb15179.x. |
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| 15280836 | Background | Sinclair R, Jolley D, Mallari R, Magee J. The reliability of horizontally sectioned scalp biopsies in the diagnosis of chronic diffuse telogen hair loss in women. J Am Acad Dermatol. 2004 Aug;51(2):189-99. doi: 10.1016/s0190-9622(03)00045-8. |
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| 27114071 | Background | Afifi L, Maranda EL, Zarei M, Delcanto GM, Falto-Aizpurua L, Kluijfhout WP, Jimenez JJ. Low-level laser therapy as a treatment for androgenetic alopecia. Lasers Surg Med. 2017 Jan;49(1):27-39. doi: 10.1002/lsm.22512. Epub 2016 Apr 25. |
| 24474647 | Background | Jimenez JJ, Wikramanayake TC, Bergfeld W, Hordinsky M, Hickman JG, Hamblin MR, Schachner LA. Efficacy and safety of a low-level laser device in the treatment of male and female pattern hair loss: a multicenter, randomized, sham device-controlled, double-blind study. Am J Clin Dermatol. 2014 Apr;15(2):115-27. doi: 10.1007/s40257-013-0060-6. |
| 29707872 | Background | Starace M, Alessandrini A, D'Acunto C, Melandri D, Bruni F, Patrizi A, Piraccini BM. Platelet-rich plasma on female androgenetic alopecia: Tested on 10 patients. J Cosmet Dermatol. 2019 Feb;18(1):59-64. doi: 10.1111/jocd.12550. Epub 2018 Apr 30. |
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| 20927234 | Background | Rakowska A, Slowinska M, Kowalska-Oledzka E, Olszewska M, Rudnicka L. Dermoscopy in female androgenic alopecia: method standardization and diagnostic criteria. Int J Trichology. 2009 Jul;1(2):123-30. doi: 10.4103/0974-7753.58555. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |