Recalcitrant Alopecia TotalisPhase 2/3NCT00997815
The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
A Phase 2/3 study testing Botulinum toxin A and Normal saline injection in people with Recalcitrant Alopecia Totalis and Recalcitrant Alopecia Universalis, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
The main purpose of this study is to determine the efficacy of intralesional botulinum toxin type A injection for recalcitrant alopecia totalis and alopecia universalis. Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for medical practice.The application of diphenylcyclopropenone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recalcitrant Alopecia Totalis, Recalcitrant Alopecia Universalis
- What is being tested?
- Botulinum toxin A and Normal saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2009to Jun 2011
- Phase
- Phase 2/3
- 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
- All patients must be over 18 years old
- All patients are diagnosed with alopecia totalis or alopecia universalis
- The alopecia condition was not responded to any treatments
Who cannot join
- Having an active inflammation on scalp area
- Allergic to botulinum toxin A of human albumin
- Has been diagnosed with neuromuscular disorders
- Taking any medication that may interfere with botulinum toxin A action
- Receiving any treatment for alopecia condition within 4 weeks
- Pregnant , breastfeeding, plan to pregnant patients
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
The main purpose of this study is to determine the efficacy of intralesional botulinum toxin type A injection for recalcitrant alopecia totalis and alopecia universalis.
Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for medical practice.The application of diphenylcyclopropenone (DPCP) is still being an standard treatment for the condition, however, there are at least thirty percentage of patients recalcitrant to this treatment.
Read more
The complete etiology of this disease has yet to be clear.Nevertheless,recent studies have demonstrated the hypothesis of neurotransmitter involvements.
There is numerous evidence in support of an imbalance of transmitters, including substance P and Calcitonin gene-related peptide.
Botulinum toxin A injection has been used to treat a neuralgiform headache and diffused alopecia areata. Both headache and hair loss have been made much in improvement. This data may support the neurotransmitter imbalance theory.
The investigators have been informed about possible effects to the alopecia condition, therefore, this study is conducted to assess the efficacy of botulinum toxin A as the novel treatment for recalcitrant alopecia totalis and alopecia universalis.
- Being tested
- Botulinum toxin A, Normal saline injection
- Keywords
- Recalcitrant, Alopecia totalis, Alopecia universalis, Botulinum toxin A
- Medical subject headings
- Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin ADrug
Also called Botox
Concentration at 2 units per 0.1 of normal saline dilution
Normal saline injectionDrug
Using normal saline 2.5 ml injected in control side
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin A | Experimental | The area of alopecia is splited into experimental and control sides by blocked randomization. Experimental sides injected with botulinum toxin A at 2 units per 0.1 ml of dilution with normal saline entire all area. Receives: Drug: Botulinum toxin A |
| Placebo | Placebo comparator | Using normal saline Receives: Drug: Normal saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection
Measured: 4 months
Secondary outcomes (1)
To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis
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 posted19 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recalcitrant Alopecia TotalisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
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 UniversitySupenya Varothai, MD, Study director, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol UniversityRasthawathana Desomchoke, MD, Principal investigator, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol UniversitySuthasinee Pattaravadee, B.Sc, Principal investigator, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997815
- Sponsor's protocol ID
- SirirajH
- Status last verified
- Aug 2012
- First submitted
- 18 Oct 2009
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
- ClinicalTrials.gov ID
- NCT00997815
- Acronym / sponsor ID
- SirirajH
- Keywords
- Recalcitrant, Alopecia totalis, Alopecia universalis, Botulinum toxin A
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 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.
The main purpose of this study is to determine the efficacy of intralesional botulinum toxin type A injection for recalcitrant alopecia totalis and alopecia universalis.
Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for medical practice.The application of diphenylcyclopropenone (DPCP) is still being an standard treatment for the condition, however, there are at least thirty percentage of patients recalcitrant to this treatment.
The complete etiology of this disease has yet to be clear.Nevertheless,recent studies have demonstrated the hypothesis of neurotransmitter involvements.
There is numerous evidence in support of an imbalance of transmitters, including substance P and Calcitonin gene-related peptide.
Botulinum toxin A injection has been used to treat a neuralgiform headache and diffused alopecia areata. Both headache and hair loss have been made much in improvement. This data may support the neurotransmitter imbalance theory.
The investigators have been informed about possible effects to the alopecia condition, therefore, this study is conducted to assess the efficacy of botulinum toxin A as the novel treatment for recalcitrant alopecia totalis and alopecia universalis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A | Experimental | Drug: Botulinum toxin AThe area of alopecia is splited into experimental and control sides by blocked randomization. Experimental sides injected with botulinum toxin A at 2 units per 0.1 ml of dilution with normal saline entire all area. |
| Placebo | Placebo comparator | Drug: Normal saline injectionUsing normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients must be over 18 years old
- All patients are diagnosed with alopecia totalis or alopecia universalis
- The alopecia condition was not responded to any treatments
Key exclusion criteria (6 listed)
- Having an active inflammation on scalp area
- Allergic to botulinum toxin A of human albumin
- Has been diagnosed with neuromuscular disorders
- Taking any medication that may interfere with botulinum toxin A action
- Receiving any treatment for alopecia condition within 4 weeks
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 AAlso: BotoxConcentration at 2 units per 0.1 of normal saline dilution | Drug | Botulinum toxin A |
| Normal saline injectionUsing normal saline 2.5 ml injected in control side | Drug | Placebo |
Primary outcome
To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection
Time frame: 4 months
1 secondary outcome
To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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
Supenya Varothai, MD study director
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Rasthawathana Desomchoke, MD principal investigator
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botulinum toxin A and Normal saline injection in people with Recalcitrant Alopecia Totalis and Recalcitrant Alopecia Universalis, run by Siriraj Hospital at 1 site 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 2 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 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis 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?
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 2 Aug 2012.