Efficacy Study of Tempol to Prevent Hair Loss From Radiot... | NCT00801086

Studies
Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain

NCT00801086

Sponsor

Mitos Pharmaceuticals

Status

Unknown status

Last Update Posted

Dec 3, 2008Estimated

Enrollment

16Estimated

Phase

Phase 2

Conditions

Alopecia

Interventions

7% (w/v) Tempol alcohol-based gel (MTS-01)
alcohol-based gel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2009Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

Dec 1, 2008

First Submission Date that Met QC Criteria

Dec 2, 2008

First Posted Date

Dec 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2008

Last Update Posted Date

Dec 3, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. The goal is to determine to what extent the experimental drug is successful in lessening the hair loss.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	MTS-01 (7% Tempol gel)	Drug: 7% (w/v) Tempol alcohol-based gel (MTS-01)
2	Placebo Comparator	Vehicle	Drug: alcohol-based gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
7% (w/v) Tempol alcohol-based gel (MTS-01)	Drug	200mL gel applied daily prior to radiation dose and removed immediately thereafter.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.		Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Metz, MD	University of Pennsylvania	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona	Recruiting	Tucson	Arizona	85724	United States

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C001803	tempol
D000431	Ethanol

Ancestor Terms

ID	Term
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided