Protocol summary
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Study aim
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A comparative study of the results of using botulinum toxin by different doses in women suffering from androgenic alopecia who referred to Razi Skin Hospital from 1401 to 1402
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Design
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Clinical trial with control group,and parallel groups, double-blind, randomized study.
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Settings and conduct
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This study is a double-blind, randomized clinical trial. Women suffering from androgenic alopecia referring to the skin clinic of Razi Hospital who meet the inclusion criteria are studied. Patients are treated with Minoxidil 5% and botulinum(Masport) in three groups with a standard protocol.
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Participants/Inclusion and exclusion criteria
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inclusion criteria:
1- Patients with grade 2/3/4 based on SINCLAIR SCALE for disease severity.
2-Having the ability for regular followup visits.
3-Not receiving treatment in the last 3 months
4-age between 18-55
5-Not having contraindications for using minoxidil or botulinum toxin .
Exlusion criteria:
1-Having needle phobia.
2- Having alopecia areata and another hair diseases(LPP).
3-Having neuromuscular disease.
4-Previous use of corticosteroids or immunosuppressive drugrs in the last 3 months.
5- Having localized infection.
6- Having internal systemic and skin disease or localized dermatosis.
7- Patients with a history of bleeding diseases or under treatment with anticoagulants .
8-Previous family or personal history of keloid.
9-Having koebner phenomenon.
10- Having symptoms of hyperandrogenism and in need for systemic drugs.
11-pregnancy and lactation.
12-Another treatments in less than 3 months.
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Intervention groups
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Control group: using minoxidil solution 5% with normal saline injection
Intervention group: using minoxidil 5% solution with the injection of 100 units botulinum toxin (Masport)
Intervention group: using minoxidil 5% solution with the injection of 200 units botulinum toxin(Masport)
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Main outcome variables
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hair volume and density
General information
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Reason for update
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I want to add a second sponsor for my trial( MDPC masoondarou pharmaceutical company) and the trade name for the botulinum toxin that will be used (Masport)
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221016056203N1
Registration date:
2022-11-19, 1401/08/28
Registration timing:
prospective
Last update:
2022-12-18, 1401/09/27
Update count:
1
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Registration date
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2022-11-19, 1401/08/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-11-22, 1401/09/01
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Expected recruitment end date
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2023-09-23, 1402/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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A comparative study of the results of using botulinum toxin by different doses in women suffering from androgenic alopecia .
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Public title
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studying the effect of botox on hormonal female hair loss
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with grade 2/4/3 based on SINCLAIR SCALE for disease severity
having the ability for regular visits
Not receiving previous treatment in the last three months
age between 18-55
not having contraindication for minoxidil 5% and botulinum toxin
Exclusion criteria:
Having needle phobia
Having alopecia areata and another hair diseases(LPP)
Having neuromuscular disease
Previous use of corticosteroids or immunosuppressive drugrs in the last 3 months
Having localized infection
Having internal systemic and skin disease or localized dermatosis.
Patients with a history of bleeding diseases or under treatment with anticoagulants
Previous family or personal history of keloid
Having koebner phenomenon
Having symptoms of hyperandrogenism and in need for systemic drugs
pregnancy and lactation
Another treatments in less than 3 months.
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Age
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From 18 years old to 55 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
63
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomized assignment of individuals to treatment and controls groups.
simple with sealed envelopes containing the material .
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Double blinded
The patient receives the injection substance (intervention or control group) in sealed envelopes that are coded. Coding is done by one of the collaborators of the project and the evaluator and the patient are blinded
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-10-22, 1401/07/30
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1401.551
Health conditions studied
1
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Description of health condition studied
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androgenetic alopecia
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ICD-10 code
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L64
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ICD-10 code description
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Androgenic alopecia
Primary outcomes
1
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Description
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Hair volume and density in qualitative and quantitative way
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Timepoint
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3 and 6 months after starting treatment
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Method of measurement
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photography - photo finder - dermoscopy -self assessment
Intervention groups
1
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Description
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Control group: using minoxidil solution 5% with normal saline injection
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Category
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Treatment - Drugs
2
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Description
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Intervention group: using minoxidil 5% solution with the injection of 100 units botulinum toxin (Masport)
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Category
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Treatment - Drugs
3
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Description
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Intervention group: using minoxidil 5% solution with the injection of 200 units botulinum toxin (Masport).
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Masoondarou pharmaceutical Company MDPC
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Individual information about the disease will be confidential and will be shared in general about the effect of the treatment on all patients
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available