Androgenetic AlopeciaPhase 2NCT05456087
Use of Botulinum Toxin in the Treatment of Androgenic Alopecia
A Phase 2 study testing incobotulinumtoxin A in people with Androgenetic Alopecia, run by Zel Skin and Laser Specialists at 1 site in United States.
Trial summary
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'. Read more about this study
- Who is it for?
- Ages 22 to 55 years
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- incobotulinumtoxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2022to Dec 2024
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be diagnosed by the investigator with mild to moderate degree of hair-pattern loss (androgenic alopecia). Mild to moderate will be defined by investigator assessment of III Vertex-V on the Norwood Scale ( for males) or 3-6 on the Savin Scale (for females).
- Subjects must be between 22-55 years of age with mild to moderate AGA with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must agree to maintain the same hair grooming and style routine during study participation.
- Sexually active females of childbearing potential participating in the study must agree to use a medically-acceptable method of contraception while receiving study product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Exception: Sexually inactive females of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the investigator's discretion, provided that they understand the possible risks involved in getting pregnant during the study and are counseled to remain sexually inactive for the duration of the study or to practice a reliable method of contraception if becoming sexually active during the study.
- Subjects must sign a written informed consent.
- Subjects must sign a photo release form.
Who cannot join
- Any systemic treatment for hair loss within the last 6 months including hormonal therapy for peri-menopausal females.
- Concurrent therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.
- Subjects under current treatments in study area with light therapy, microneedling, Platelet-rich Plasma, prostaglandin analogues, ketoconazole, hair transplant or any method deemed unacceptable by the investigator.
- Any history of drug interaction, such as, aminoglycoside antibiotics, penicillamine, quinine and calcium channel blockers
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- History of allergic reaction to similar products (Botox® or Dysport®)
Show all 14Show fewer
- Albumin sensitivity (allergy to eggs)
- Subjects with any signs of infection at the injection sites
- Active cold or sinus infection
- Any dermatologic or systemic disorder, which in the investigator's opinion, may interfere with the treatment. Examples of such disorders include neuromuscular disorders, hypertrophic scarring, keloidal scarring, bleeding disorders, subjects on immunosuppressive medications, and lupus erythematosus.
- Subjects who are pregnant, breast feeding or planning a pregnancy during the study period.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
- Participation in another research study (currently or within the last 30 days).
- All volunteers unwilling to sign the consent forms after being informed of their obligations and risks that they might encounter as a participant in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
ZelSkin and Laser Specialists
Edina, Minnesota, 55424
About this study
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.
Read the detailed description
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.
- Conditions
- Androgenetic Alopecia
- Being tested
- incobotulinumtoxin A
- Keywords
- Patterned Hair Loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incobotulinumtoxin ADrug
Also called Xeomin
Up to 150 units of incobotulinumtoxin A will be injected at up to 30 injection sites within the hair loss area
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: incobotulinumtoxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 30, Day 90, Day 180, and Day 270
Secondary outcomes (8)
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.
Measured: Day 30
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start12 Aug 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zel Skin and Laser Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Aesthetics Inc.
- Responsible party
- Principal investigator, Brian Zelickson, Zel Skin and Laser Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456087
- Sponsor's protocol ID
- ZEL-IIT5773
- Status last verified
- Mar 2024
- First submitted
- 12 Apr 2022
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 30394586Cash 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.
PubMed 10583042Bienova 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.
PubMed 15818439Norwood OT. Incidence of female androgenetic alopecia (female pattern alopecia). Dermatol Surg. 2001 Jan;27(1):53-4.
PubMed 11231244Starace M, Orlando G, Alessandrini A, Piraccini BM. Female Androgenetic Alopecia: An Update on Diagnosis and Management. Am J Clin Dermatol. 2020 Feb;21(1):69-84. doi: 10.1007/s40257-019-00479-x.
PubMed 31677111Inui S, Itami S. Androgen actions on the human hair follicle: perspectives. Exp Dermatol. 2013 Mar;22(3):168-71. doi: 10.1111/exd.12024. Epub 2012 Sep 28.
PubMed 23016593Ramos PM, Miot HA. Female Pattern Hair Loss: a clinical and pathophysiological review. An Bras Dermatol. 2015 Jul-Aug;90(4):529-43. doi: 10.1590/abd1806-4841.20153370.
PubMed 26375223Cousen P, Messenger A. Female pattern hair loss in complete androgen insensitivity syndrome. Br J Dermatol. 2010 May;162(5):1135-7. doi: 10.1111/j.1365-2133.2010.09661.x. Epub 2010 Feb 1.
PubMed 20128792Sinclair R. Winding the clock back on female androgenetic alopecia. Br J Dermatol. 2012 Jun;166(6):1157-8. doi: 10.1111/j.1365-2133.2012.10934.x. No abstract available.
PubMed 22626036Cotsarelis G, Millar SE. Towards a molecular understanding of hair loss and its treatment. Trends Mol Med. 2001 Jul;7(7):293-301. doi: 10.1016/s1471-4914(01)02027-5.
PubMed 11425637Goldman BE, Fisher DM, Ringler SL. Transcutaneous PO2 of the scalp in male pattern baldness: a new piece to the puzzle. Plast Reconstr Surg. 1996 May;97(6):1109-16; discussion 1117. doi: 10.1097/00006534-199605000-00003.
PubMed 8628793Ramos PM, Brianezi G, Martins AC, da Silva MG, Marques ME, Miot HA. Apoptosis in follicles of individuals with female pattern hair loss is associated with perifollicular microinflammation. Int J Cosmet Sci. 2016 Dec;38(6):651-654. doi: 10.1111/ics.12341. Epub 2016 Jun 1.
PubMed 27163333Garza 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.
PubMed 22440736Jaworsky C, Kligman AM, Murphy GF. Characterization of inflammatory infiltrates in male pattern alopecia: implications for pathogenesis. Br J Dermatol. 1992 Sep;127(3):239-46. doi: 10.1111/j.1365-2133.1992.tb00121.x.
PubMed 1390168Gupta M, Mysore V. Classifications of Patterned Hair Loss: A Review. J Cutan Aesthet Surg. 2016 Jan-Mar;9(1):3-12. doi: 10.4103/0974-2077.178536.
PubMed 27081243
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Botulinum Toxin in the Treatment of Androgenic Alopecia
- ClinicalTrials.gov ID
- NCT05456087
- Acronym / sponsor ID
- ZEL-IIT5773
- Conditions
- Androgenetic Alopecia
- Keywords
- Patterned Hair Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zel Skin and Laser SpecialistsUniversity, hospital or other
- Collaborators
- Merz Aesthetics Inc.
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single treatment with Xeomin® (incobotulinumtoxin A) | Experimental | Drug: incobotulinumtoxin AIndividual 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. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must be diagnosed by the investigator with mild to moderate degree of hair-pattern loss (androgenic alopecia). Mild to moderate will be defined by investigator assessment of III Vertex-V on the Norwood Scale ( for males) or 3-6 on the Savin Scale (for females).
- Subjects must be between 22-55 years of age with mild to moderate AGA with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must agree to maintain the same hair grooming and style routine during study participation.
- Sexually active females of childbearing potential participating in the study must agree to use a medically-acceptable method of contraception while receiving study product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Exception: Sexually inactive females of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the investigator's discretion, provided that they understand the possible risks involved in getting pregnant during the study and are counseled to remain sexually inactive for the duration of the study or to practice a reliable method of contraception if becoming sexually active during the study.
- Subjects must sign a written informed consent.
Key exclusion criteria (14 listed)
- Any systemic treatment for hair loss within the last 6 months including hormonal therapy for peri-menopausal females.
- Concurrent therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.
- Subjects under current treatments in study area with light therapy, microneedling, Platelet-rich Plasma, prostaglandin analogues, ketoconazole, hair transplant or any method deemed unacceptable by the investigator.
- Any history of drug interaction, such as, aminoglycoside antibiotics, penicillamine, quinine and calcium channel blockers
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| incobotulinumtoxin AAlso: XeominUp to 150 units of incobotulinumtoxin A will be injected at up to 30 injection sites within the hair loss area | Drug | Single treatment with Xeomin® (incobotulinumtoxin A) |
Primary outcome
Changes from baseline in hair count per cm2 (number of hairs per follicular unit)
Time frame: Day 30, Day 90, Day 180, and Day 270
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.
Changes from baseline in sum of hair width per cm2 (total scalp coverage)
Time frame: Day 30, Day 90, Day 180, and Day 270
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.
Changes from baseline in Terminal:Vellus ratio (number of terminal hairs for every one vellus hair).
Time frame: Day 30, Day 90, Day 180, and Day 270
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.
Changes from baseline in Average hairs per follicular unit (average number of hairs within a hair follicle).
Time frame: Day 30, Day 90, Day 180, and Day 270
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.
Changes from baseline in Average hair width (microns) (average thickness of hair in microns).
Time frame: Day 30, Day 90, Day 180, and Day 270
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.
Changes from baseline in Follicle count per cm2 (number of follicles per square centimeter).
Time frame: Day 30, Day 90, Day 180, and Day 270
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.
Mean Inter-follicular distance (mm) (mean distance between follicular units).
Time frame: Day 30, Day 90, Day 180, and Day 270
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.
8 secondary outcomes
Change from baseline in balding scalp hair recovery assessed by study investigator
Time frame: Day 30
Change from baseline in balding scalp hair recovery assessed by study investigator
Time frame: Day 90
Change from baseline in balding scalp hair recovery assessed by study investigator
Time frame: Day 180
Change from baseline in balding scalp hair recovery assessed by study investigator
Time frame: Day 270
Change from baseline in balding scalp hair recovery assessed by study participant
Time frame: Day 30
Change from baseline in balding scalp hair recovery assessed by study participant
Time frame: Day 90
Change from baseline in balding scalp hair recovery assessed by study participant
Time frame: Day 180
Change from baseline in balding scalp hair recovery assessed by study participant
Time frame: Day 270
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: PubMed 30394586Russo 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.
- Background: PubMed 10583042Cash 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.
- Background: PubMed 15818439Bienova 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.
- Background: PubMed 11231244Norwood OT. Incidence of female androgenetic alopecia (female pattern alopecia). Dermatol Surg. 2001 Jan;27(1):53-4.
- Background: PubMed 31677111Starace M, Orlando G, Alessandrini A, Piraccini BM. Female Androgenetic Alopecia: An Update on Diagnosis and Management. Am J Clin Dermatol. 2020 Feb;21(1):69-84. doi: 10.1007/s40257-019-00479-x.
- Background: PubMed 23016593Inui S, Itami S. Androgen actions on the human hair follicle: perspectives. Exp Dermatol. 2013 Mar;22(3):168-71. doi: 10.1111/exd.12024. Epub 2012 Sep 28.
- Background: PubMed 26375223Ramos PM, Miot HA. Female Pattern Hair Loss: a clinical and pathophysiological review. An Bras Dermatol. 2015 Jul-Aug;90(4):529-43. doi: 10.1590/abd1806-4841.20153370.
- Background: PubMed 20128792Cousen P, Messenger A. Female pattern hair loss in complete androgen insensitivity syndrome. Br J Dermatol. 2010 May;162(5):1135-7. doi: 10.1111/j.1365-2133.2010.09661.x. Epub 2010 Feb 1.
- Background: PubMed 22626036Sinclair R. Winding the clock back on female androgenetic alopecia. Br J Dermatol. 2012 Jun;166(6):1157-8. doi: 10.1111/j.1365-2133.2012.10934.x. No abstract available.
- Background: PubMed 11425637Cotsarelis G, Millar SE. Towards a molecular understanding of hair loss and its treatment. Trends Mol Med. 2001 Jul;7(7):293-301. doi: 10.1016/s1471-4914(01)02027-5.
- Background: PubMed 8628793Goldman BE, Fisher DM, Ringler SL. Transcutaneous PO2 of the scalp in male pattern baldness: a new piece to the puzzle. Plast Reconstr Surg. 1996 May;97(6):1109-16; discussion 1117. doi: 10.1097/00006534-199605000-00003.
- Background: PubMed 27163333Ramos PM, Brianezi G, Martins AC, da Silva MG, Marques ME, Miot HA. Apoptosis in follicles of individuals with female pattern hair loss is associated with perifollicular microinflammation. Int J Cosmet Sci. 2016 Dec;38(6):651-654. doi: 10.1111/ics.12341. Epub 2016 Jun 1.
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing incobotulinumtoxin A in people with Androgenetic Alopecia, run by Zel Skin and Laser Specialists at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in hair count per cm2 (number of hairs per follicular unit) (time frame: Day 30, Day 90, Day 180, and Day 270). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05456087, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.