Alopecia AreataNCT00999869
The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata
A study testing Botulinum toxin type A and Triamcinolone acetonide in people with Alopecia Areata, run by Siriraj Hospital at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Botulinum toxin type A and Triamcinolone acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesThailand
- Study dates
- Nov 2009to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Siriraj hospital
Bangkok, Bangkok, 10700
Rattapon Thuangtong, M.D., rattaponthuangtong@yahoo.com
- Not yet recruiting
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Rattapon Thuangtong, MD., (66)-2-419-7000 ext. 4332, rattaponthuangtong@yahoo.com
Supenya Varathai, MD., (66)-2-419-7000 ext. 4332, supenya_v@yahoo.com
About this study
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.
Read more
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.
Read the 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
- Conditions
- Alopecia Areata
- Being tested
- Botulinum toxin type A, Triamcinolone acetonide
- Keywords
- Newly diagnosed, Alopecia areata, Botulinum toxin A, Corticosteroid, Intralesional injection
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox( Allergan Inc.)
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
Triamcinolone acetonideDrug
Also called Kenacort
Using concentration at 10 mg/ml and equal amount of botulinum toxin A dilution
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin A | Experimental | 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 ). Receives: Drug: Botulinum toxin type A |
| Triamcinolone acetonide | Active comparator | At visit0, patients will be injection with triamcinolone acetonide concentration at 10 mg/ml on the comparison side Receives: Drug: Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of terminal hair regrowth after intralesional botulinum toxin A injection
Measured: 4 months
Secondary outcomes (1)
Possible side effects of intralesional botulinum toxin a injection
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rattapon Thuangtong, Siriraj Hospital
- Investigators
- Rattapon Thoungtong, MD., Study chair, Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,ThailandSupenya Varothai, MD., Study director, Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,ThailandRasthawathana Desomchoke, MD., Principal investigator, Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,ThailandKumpol Aiempanakit, M.D., Principal investigator, Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999869
- Sponsor's protocol ID
- SirirajH-2
- Status last verified
- Aug 2012
- First submitted
- 21 Oct 2009
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton LJ 3rd. Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989. Mayo Clin Proc. 1995 Jul;70(7):628-33. doi: 10.4065/70.7.628.
PubMed 7791384McDonagh AJ, Messenger AG. The pathogenesis of alopecia areata. Dermatol Clin. 1996 Oct;14(4):661-70. doi: 10.1016/s0733-8635(05)70392-2.
PubMed 9238324Jackow C, Puffer N, Hordinsky M, Nelson J, Tarrand J, Duvic M. Alopecia areata and cytomegalovirus infection in twins: genes versus environment? J Am Acad Dermatol. 1998 Mar;38(3):418-25. doi: 10.1016/s0190-9622(98)70499-2.
PubMed 9520023Delamere FM, Sladden MM, Dobbins HM, Leonardi-Bee J. Interventions for alopecia areata. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD004413. doi: 10.1002/14651858.CD004413.pub2.
PubMed 18425901Charuwichitratana S, Wattanakrai P, Tanrattanakorn S. Randomized double-blind placebo-controlled trial in the treatment of alopecia areata with 0.25% desoximetasone cream. Arch Dermatol. 2000 Oct;136(10):1276-7. doi: 10.1001/archderm.136.10.1276. No abstract available.
PubMed 11030789Kar BR, Handa S, Dogra S, Kumar B. Placebo-controlled oral pulse prednisolone therapy in alopecia areata. J Am Acad Dermatol. 2005 Feb;52(2):287-90. doi: 10.1016/j.jaad.2004.10.873.
PubMed 15692475Lassus A, Eskelinen A, Johansson E. Treatment of alopecia areata with three different PUVA modalities. Photodermatol. 1984 Jun;1(3):141-4.
PubMed 6527956Mitchell AJ, Douglass MC. Topical photochemotherapy for alopecia areata. J Am Acad Dermatol. 1985 Apr;12(4):644-9. doi: 10.1016/s0190-9622(85)70088-6.
PubMed 3989026Tosti A, De Padova MP, Minghetti G, Veronesi S. Therapies versus placebo in the treatment of patchy alopecia areata. J Am Acad Dermatol. 1986 Aug;15(2 Pt 1):209-10. doi: 10.1016/s0190-9622(86)70158-8.
PubMed 3528241Vestey JP, Savin JA. A trial of 1% minoxidil used topically for severe alopecia areata. Acta Derm Venereol. 1986;66(2):179-80.
PubMed 2424249Fransway AF, Muller SA. 3 percent topical minoxidil compared with placebo for the treatment of chronic severe alopecia areata. Cutis. 1988 Jun;41(6):431-5.
PubMed 3292159Price VH. Double-blind, placebo-controlled evaluation of topical minoxidil in extensive alopecia areata. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):730-6. doi: 10.1016/s0190-9622(87)70095-4.
PubMed 3549809Fiedler-Weiss VC, Buys CM. Evaluation of anthralin in the treatment of alopecia areata. Arch Dermatol. 1987 Nov;123(11):1491-3.
PubMed 3314718van der Steen PH, van Baar HM, Happle R, Boezeman JB, Perret CM. Prognostic factors in the treatment of alopecia areata with diphenylcyclopropenone. J Am Acad Dermatol. 1991 Feb;24(2 Pt 1):227-30. doi: 10.1016/0190-9622(91)70032-w.
PubMed 2007667Gupta AK, Ellis CN, Cooper KD, Nickoloff BJ, Ho VC, Chan LS, Hamilton TA, Tellner DC, Griffiths CE, Voorhees JJ. Oral cyclosporine for the treatment of alopecia areata. A clinical and immunohistochemical analysis. J Am Acad Dermatol. 1990 Feb;22(2 Pt 1):242-50. doi: 10.1016/0190-9622(90)70032-d.
PubMed 2138175
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata
- ClinicalTrials.gov ID
- NCT00999869
- Acronym / sponsor ID
- SirirajH-2
- Conditions
- Alopecia Areata
- Keywords
- Newly diagnosed, Alopecia areata, Botulinum toxin A, Corticosteroid, Intralesional injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 22 Oct 2009 (estimated)
- 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A | Experimental | Drug: Botulinum toxin type AAt 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 ). |
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone acetonideAt visit0, patients will be injection with triamcinolone acetonide concentration at 10 mg/ml on the comparison side |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Botulinum toxin type AAlso: Botox( Allergan Inc.)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 | Drug | Botulinum toxin A |
| Triamcinolone acetonideAlso: KenacortUsing concentration at 10 mg/ml and equal amount of botulinum toxin A dilution | Drug | Triamcinolone acetonide |
Primary outcome
The percentage of terminal hair regrowth after intralesional botulinum toxin A injection
Time frame: 4 months
1 secondary outcome
Possible side effects of intralesional botulinum toxin a injection
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Background: PubMed 7791384Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton LJ 3rd. Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989. Mayo Clin Proc. 1995 Jul;70(7):628-33. doi: 10.4065/70.7.628.
- Background: PubMed 9238324McDonagh AJ, Messenger AG. The pathogenesis of alopecia areata. Dermatol Clin. 1996 Oct;14(4):661-70. doi: 10.1016/s0733-8635(05)70392-2.
- Background: PubMed 9520023Jackow C, Puffer N, Hordinsky M, Nelson J, Tarrand J, Duvic M. Alopecia areata and cytomegalovirus infection in twins: genes versus environment? J Am Acad Dermatol. 1998 Mar;38(3):418-25. doi: 10.1016/s0190-9622(98)70499-2.
- Background: PubMed 18425901Delamere FM, Sladden MM, Dobbins HM, Leonardi-Bee J. Interventions for alopecia areata. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD004413. doi: 10.1002/14651858.CD004413.pub2.
- Background: PubMed 11030789Charuwichitratana S, Wattanakrai P, Tanrattanakorn S. Randomized double-blind placebo-controlled trial in the treatment of alopecia areata with 0.25% desoximetasone cream. Arch Dermatol. 2000 Oct;136(10):1276-7. doi: 10.1001/archderm.136.10.1276. No abstract available.
- Background: PubMed 15692475Kar BR, Handa S, Dogra S, Kumar B. Placebo-controlled oral pulse prednisolone therapy in alopecia areata. J Am Acad Dermatol. 2005 Feb;52(2):287-90. doi: 10.1016/j.jaad.2004.10.873.
- Background: PubMed 6527956Lassus A, Eskelinen A, Johansson E. Treatment of alopecia areata with three different PUVA modalities. Photodermatol. 1984 Jun;1(3):141-4.
- Background: PubMed 3989026Mitchell AJ, Douglass MC. Topical photochemotherapy for alopecia areata. J Am Acad Dermatol. 1985 Apr;12(4):644-9. doi: 10.1016/s0190-9622(85)70088-6.
- Background: PubMed 3528241Tosti A, De Padova MP, Minghetti G, Veronesi S. Therapies versus placebo in the treatment of patchy alopecia areata. J Am Acad Dermatol. 1986 Aug;15(2 Pt 1):209-10. doi: 10.1016/s0190-9622(86)70158-8.
- Background: PubMed 2424249Vestey JP, Savin JA. A trial of 1% minoxidil used topically for severe alopecia areata. Acta Derm Venereol. 1986;66(2):179-80.
- Background: PubMed 3292159Fransway AF, Muller SA. 3 percent topical minoxidil compared with placebo for the treatment of chronic severe alopecia areata. Cutis. 1988 Jun;41(6):431-5.
- Background: PubMed 3549809Price VH. Double-blind, placebo-controlled evaluation of topical minoxidil in extensive alopecia areata. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):730-6. doi: 10.1016/s0190-9622(87)70095-4.
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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.
Rattapon Thoungtong, MD. study chair
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
Supenya Varothai, MD. study director
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
Rasthawathana Desomchoke, MD. principal investigator
Department of Dermatology, Faculty of medicine Siriraj Hospital, Mahidol University,Thailand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A and Triamcinolone acetonide in people with Alopecia Areata, run by Siriraj Hospital at 2 sites in Thailand.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rattapon Thuangtong, MD. ((66)-2-419-7000 ext. 4332, rattaponthuangtong@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of terminal hair regrowth after intralesional botulinum toxin A injection (time frame: 4 months). 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 NCT00999869, which also lists 25 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 7 Aug 2012.