AlopeciaPhase 2NCT00713154
Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy
A Phase 2 study testing MTS-01 in people with Alopecia, run by Mitos Pharmaceuticals.
Trial summary
The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain 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?
- MTS-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Sep 2008
- 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
- is >/= 18 years of age
- Has metastatic cancer to the brain for which palliative or prophylactic whole brain radiotherapy is recommended. A histological diagnosis of cancer will be required, however, a biopsy of the brain metastases will not be required
- Can understand and sign the IRB/IEC approved informed consent, can communicate with the Investigator, and can understand with the requirements of the protocol
- has signed the HIPAA authorization
Who cannot join
- -
About this study
Official title: A Phase II, Double-Blind Placebo-Controlled, Parallel Group Study of the Safety and Preliminary Efficacy of MTS-01, for the Prevention of Alopecia Induced by Whole Brain Radiotherapy
The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy
Read the detailed description
Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy
- Conditions
- Alopecia
- Being tested
- MTS-01, Placebo
- Keywords
- Radiotherapy, induced
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTS-01Drug
MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment
PlaceboDrug
Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo group Receives: Drug: Placebo |
| 2 | Active comparator | Control Group Receives: Drug: MTS-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator assessment of hair loss using a 10 point scale
Measured: up to 12 weeks
Secondary outcomes (1)
A time to event analysis of the hair loss
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startApr 2007
- Primary completionSep 2007
- Study completionSep 2008 (estimated)
Why it stopped: Major planned study protocol modifications
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitos Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713154
- Sponsor's protocol ID
- Mito 02-02
- Status last verified
- Jul 2008
- First submitted
- 9 Jul 2008
- Last updated
- 11 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind Placebo-Controlled, Parallel Group Study of the Safety and Preliminary Efficacy of MTS-01, for the Prevention of Alopecia Induced by Whole Brain Radiotherapy
- ClinicalTrials.gov ID
- NCT00713154
- Acronym / sponsor ID
- Mito 02-02
- Conditions
- Alopecia
- Keywords
- Radiotherapy, induced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Major planned study protocol modifications
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mitos PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2008 (estimated)
- First posted
- 11 Jul 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.
The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy
Detailed description
Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo group |
| 2 | Active comparator | Drug: MTS-01Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- is >/= 18 years of age
- Has metastatic cancer to the brain for which palliative or prophylactic whole brain radiotherapy is recommended. A histological diagnosis of cancer will be required, however, a biopsy of the brain metastases will not be required
- Can understand and sign the IRB/IEC approved informed consent, can communicate with the Investigator, and can understand with the requirements of the protocol
- has signed the HIPAA authorization
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| MTS-01MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment | Drug | 2 |
| PlaceboPlacebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment | Drug | 1 |
Primary outcome
Investigator assessment of hair loss using a 10 point scale
Time frame: up to 12 weeks
1 secondary outcome
A time to event analysis of the hair loss
Time frame: up to 12 weeks
Results and safety
The study was stopped early (reason given: Major planned study protocol modifications). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTS-01 in people with Alopecia, run by Mitos Pharmaceuticals.
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 1 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: stopped early, as of the sponsor's last update on 11 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Major planned study protocol modifications). Results are not available in the source record.
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?
Investigator assessment of hair loss using a 10 point scale (time frame: up to 12 weeks). 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 11 Jul 2008.