The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata
Primary Purpose
Alopecia Areata
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Botulinum toxin type A
Triamcinolone acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata focused on measuring Newly diagnosed, Alopecia areata, Botulinum toxin A, Corticosteroid, Intralesional injection
Eligibility Criteria
Inclusion criteria
- Patients must be above 18 years old
- Newly diagnosed with multiple alopecia areata
- Patient has lesions on the both side of the scalp.
- Lesions's diameter varies between 2-6 cms
Exclusion criteria
- Having active scalp inflammation
- Allergic to botulinum toxin A or human albumin
- Receiving any medication that interfere efficacy of botulinum toxin such as macrolides antimicrobial agents or neuromuscular medications
- Diagnosed with neuromuscular diseases such as Myasthenia gravis
- Pregnant, breast feeding, plan to pregnant patients
Sites / Locations
- Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University
- Siriraj hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Botulinum toxin A
Triamcinolone acetonide
Arm Description
At first visit, patients will be randomized by blocked randomization into 2 sides of scalp. Experimental side will be injected with botulinum toxin A ( Botox) 2 units per 6.05 cm2 of lesion ( Concentration 2 units of Botox per 0.1 ml of normal saline ).
At visit0, patients will be injection with triamcinolone acetonide concentration at 10 mg/ml on the comparison side
Outcomes
Primary Outcome Measures
The percentage of terminal hair regrowth after intralesional botulinum toxin A injection
Secondary Outcome Measures
Possible side effects of intralesional botulinum toxin a injection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00999869
Brief Title
The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata
Official Title
The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Alopecia areata is one of the most common cause of non-scarring alopecia. The pathogenesis is still unclear, however, it is believed to be an autoimmune disease. This disease is not a life-threatening condition but it has a significant psychological impact to patient's quality of life.
Many triggers have been proposed such as viral infection, stress and neurologic factors. There are many studies show the correlation between disease activities and neurotransmitters level. Substance P and calcitonin gene-related peptide play major role in early stage of disease. These substances cause imbalance of CD4/CD8 lymphocyte in pathologic site and loss of immune privilege of hair follicles.
The conventional treatment of alopecia areata with intralesional corticosteroid injection might treat the end of pathogenesis process.
There is no therapeutic intervention for the origin of disease. Fortunately, botulinum toxin A could be a novel treatment of alopecia areata. The botulinum toxin A demonstrates inhibition release of substance P in many publications.
To sum up, the treatment of alopecia areata with intralesional corticosteroid injection still be a standard treatment, nevertheless, patients have to receive this treatment every month until regrowth of scalp hair. Corticosteroid injection have several side effects, for example, skin atrophy, pigmentary change and hypothalamic-pituitary-adrenal axis suppression. Moreover, injection pain is also affect to psychological aspect .
This study purpose is to evaluate the efficacy of botulinum toxin A for alopecia areata and reduce corticosteroid side effects, as well as, others opportunity cost. There is no prospective, randomized-controlled trial of comparison study between botulinum toxin A injection and corticosteroid injection for alopecia areata, therefore, investigators conduct this study for the greatest benefit to alopecia areata patients and for the future research in disease etiology.
Detailed Description
Inclusion criteria
Patients must be above 18 years old
Newly diagnosed with multiple alopecia areata
Patient has lesions on the both side of the scalp.
Lesions's diameter varies between 2-6 cms
Exclusion criteria
Having active scalp inflammation
Allergic to botulinum toxin A or human albumin
Receiving any medication that interfere efficacy of botulinum toxin such as macrolides antimicrobial agents or neuromuscular medications
Diagnosed with neuromuscular diseases such as Myasthenia gravis
Pregnant, breast feeding, plan to pregnant patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Newly diagnosed, Alopecia areata, Botulinum toxin A, Corticosteroid, Intralesional injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin A
Arm Type
Experimental
Arm Description
At first visit, patients will be randomized by blocked randomization into 2 sides of scalp. Experimental side will be injected with botulinum toxin A ( Botox) 2 units per 6.05 cm2 of lesion ( Concentration 2 units of Botox per 0.1 ml of normal saline ).
Arm Title
Triamcinolone acetonide
Arm Type
Active Comparator
Arm Description
At visit0, patients will be injection with triamcinolone acetonide concentration at 10 mg/ml on the comparison side
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Botox( Allergan Inc.)
Intervention Description
Using concentration at 2 units per 0.1 of dilution with normal saline Injection in the first visit and follow up at 1 week, 1,2,3 and 4 months after injection
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide
Other Intervention Name(s)
Kenacort
Intervention Description
Using concentration at 10 mg/ml and equal amount of botulinum toxin A dilution
Primary Outcome Measure Information:
Title
The percentage of terminal hair regrowth after intralesional botulinum toxin A injection
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Possible side effects of intralesional botulinum toxin a injection
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Patients must be above 18 years old
Newly diagnosed with multiple alopecia areata
Patient has lesions on the both side of the scalp.
Lesions's diameter varies between 2-6 cms
Exclusion criteria
Having active scalp inflammation
Allergic to botulinum toxin A or human albumin
Receiving any medication that interfere efficacy of botulinum toxin such as macrolides antimicrobial agents or neuromuscular medications
Diagnosed with neuromuscular diseases such as Myasthenia gravis
Pregnant, breast feeding, plan to pregnant patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rattapon Thuangtong, MD.
Phone
(66)-2-419-7000
Ext
4332
Email
rattaponthuangtong@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Supenya Varothia, MD.
Phone
(66)-2-419-7000
Ext
4332
Email
supenya_v@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rattapon Thoungtong, MD.
Organizational Affiliation
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Supenya Varothai, MD.
Organizational Affiliation
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rasthawathana Desomchoke, MD.
Organizational Affiliation
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kumpol Aiempanakit, M.D.
Organizational Affiliation
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rattapon Thuangtong, MD.
Phone
(66)-2-419-7000
Ext
4332
Email
rattaponthuangtong@yahoo.com
First Name & Middle Initial & Last Name & Degree
Supenya Varathai, MD.
Phone
(66)-2-419-7000
Ext
4332
Email
supenya_v@yahoo.com
First Name & Middle Initial & Last Name & Degree
Suthasinee Pattaravadee, B.Sc
Facility Name
Siriraj hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rattapon Thuangtong, M.D.
Email
rattaponthuangtong@yahoo.com
12. IPD Sharing Statement
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The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata
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