AlopeciaPhase 2NCT00801086
Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain
A Phase 2 study testing 7% (w/v) Tempol alcohol-based gel (MTS-01) and alcohol-based gel in people with Alopecia, run by Mitos Pharmaceuticals at 2 sites in United States.
Trial summary
Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. In this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia
- What is being tested?
- 7% (w/v) Tempol alcohol-based gel (MTS-01) and alcohol-based gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Jun 2010
- Phase
- Phase 2
- 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
- Metastatic cancer to the brain for which palliative whole brain radiotherapy is recommended.
- Hair that covers the scalp and is at least 1/4 inch in length
Who cannot join
- Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.
- Pre-existing alopecia
- Previous brain radiotherapy
- scalp metastases or scalp wounds
- use of hair dyes
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Deborah Smith, RN, 215-662-6694
Jim Metz, MD
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Jamie Holt, 520-694-6000 ext. 2970
Baldassarre Stea, MD,PhD
About this study
Official title: Phase II Double-Blind, Placebo-Controlled Study of the Safety and Preliminary Effectiveness of MTS-01 for the Prevention of Alopecia Induced by Whole Brain Radiotherapy
Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. In this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. The goal is to determine to what extent the experimental drug is successful in lessening the hair loss.
- Conditions
- Alopecia
- Being tested
- 7% (w/v) Tempol alcohol-based gel (MTS-01), alcohol-based gel
- Keywords
- Alopecia, Hair loss, Radiation, Whole brain radiotherapy, Radiation-induced alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7% (w/v) Tempol alcohol-based gel (MTS-01)Drug
200mL gel applied daily prior to radiation dose and removed immediately thereafter.
alcohol-based gelDrug
200mL gel applied daily prior to radiation dose and removed immediately thereafter
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MTS-01 (7% Tempol gel) Receives: Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01) |
| 2 | Placebo comparator | Vehicle Receives: Drug: alcohol-based gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.
Measured: Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitos Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Metz, MD, Study chair, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801086
- Sponsor's protocol ID
- MITO 02-03
- Status last verified
- Dec 2008
- First submitted
- 1 Dec 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Double-Blind, Placebo-Controlled Study of the Safety and Preliminary Effectiveness of MTS-01 for the Prevention of Alopecia Induced by Whole Brain Radiotherapy
- ClinicalTrials.gov ID
- NCT00801086
- Acronym / sponsor ID
- MITO 02-03
- Conditions
- Alopecia
- Keywords
- Alopecia, Hair loss, Radiation, Whole brain radiotherapy, Radiation-induced alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mitos PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 3 Dec 2008 (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.
Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. In this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. The goal is to determine to what extent the experimental drug is successful in lessening the hair loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01)MTS-01 (7% Tempol gel) |
| 2 | Placebo comparator | Drug: alcohol-based gelVehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Metastatic cancer to the brain for which palliative whole brain radiotherapy is recommended.
- Hair that covers the scalp and is at least 1/4 inch in length
Key exclusion criteria (5 listed)
- Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.
- Pre-existing alopecia
- Previous brain radiotherapy
- scalp metastases or scalp wounds
- use of hair dyes
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 |
|---|---|---|
| 7% (w/v) Tempol alcohol-based gel (MTS-01)200mL gel applied daily prior to radiation dose and removed immediately thereafter. | Drug | 1 |
| alcohol-based gel200mL gel applied daily prior to radiation dose and removed immediately thereafter | Drug | 2 |
Primary outcome
Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.
Time frame: Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2008.
Related trials for Alopecia
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
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.
James Metz, MD study chair
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7% (w/v) Tempol alcohol-based gel (MTS-01) and alcohol-based gel in people with Alopecia, run by Mitos Pharmaceuticals at 2 sites 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 2 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 3 Dec 2008. 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 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo. (time frame: Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.). 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 3 Dec 2008.