Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063076
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2003-06-19
Brief Title:
Phase II Randomized Bilateral Comparison of Topical Targretin Gel 1 in Alopecia Areata
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin Gel 1 in Alopecia Areata
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to find the most effective dose of Targretin bexarotene Gel 1 that can be given to patients as a treatment for alopecia areata The safety and tolerability of this drug will also be studied
Objectives
1 Determine the safety and tolerability of Targretin Gel 1 in the treatment of patients with alopecia areata
2 Determine the efficacy of Targretin Gel 1 in the treatment of patients with alopecia areata
Objectives
1 Determine the safety and tolerability of Targretin Gel 1 in the treatment of patients with alopecia areata
2 Determine the efficacy of Targretin Gel 1 in the treatment of patients with alopecia areata
Detailed Description:
Targretin bexarotene Gel 1 a synthetic vitamin A compound that is approved for the topical treatment and oral treatment of cutaneous T cell lymphoma CTCL Vitamin A compounds can influence the growth of skin cells and can cause the death of T-cells Researchers hope that the bexarotene may get rid of T-cells around the hair follicles in AA alopecia areata lesions
Before treatment starts patients will have a complete medical history and a brief physical exam Researchers will ask about alopecia disease history date of first diagnosis and earlier treatments and responses Blood test about 4 teaspoons will be performed before and after the end of treatment Additional blood tests will be done if needed Women able to have children must have a negative blood pregnancy test within 7 days before the start of treatment Blood pregnancy test must be repeated once a month while receiving treatment
Participants in this study will be randomly assigned as in the toss of a coin to treat alopecia areata lesions on only one half of their head Half of the participants will have the left side treated while the other half will have the right side treated Sealed envelopes will be given to participants telling them which side of the head to treat The other half of the head will remain untreated and serve as the control
Patients will treat alopecia lesions on one-half of the head including facial hair as designated by the investigator The other half of the head will have control untreated alopecia lesions Up to 5 index lesions for treatment and 5 control lesions will be designated at baseline to follow and measure during the study Patients will be treated with Targretin gel 1 in a dose escalation regimen starting at once every day At the start of Week 3 patients will begin applications of twice a day applications if tolerated Patients will continue BID dosing if tolerated unless the investigator determines a further increase in application frequency may benefit the patient and the patient agrees to comply
Patients will be seen at baseline and at weeks 2 4 8 12 16 20 24 and at a 4-week follow-up Telephone evaluations will be done at week 1 and as needed
Study visits for evaluation of safety and efficacy will be made at Week 2 and 4 after the start of treatment and then every 4 weeks up until Week 24 Telephone safety evaluations will also be made at Week 1 and other times as needed
Skin irritation or changes in health during the study may require participants to stop treatment or withdraw from the study
At withdrawal from the study about 4 teaspoons of blood will be drawn The total study duration is 24 Weeks with a 4-week follow-up period At the 4-week follow-up visit a physical exam including measurement of vital signs and weight will be performed An evaluation of both treated and untreated sides of the head will be performed
Patients who show a response at 6 months 24 weeks will be given the option to continue therapy for an additional 6 months and will be able to apply the medication to both sides of the head Patients will come every 2 months 3 additional visits and will have the same examination as they have had during the study with evaluation of irritation hair loss hair thickness measurement of lesions and the physicians global assessment which is the evaluation of hair re-growth The same dose adjustment and withdrawal from treatment will be applied during this 6-month period Every 2 months blood about 2 tablespoons will be drawn for pregnancy tests and to look at your triglycerides fat levels and complete blood cell counts
This is an investigational study Targretin Gel 1 is commercially available and approved by the FDA for use in the treatment of cutaneous lesions in patients with CTCL Initially up to 42 participants will be enrolled in the study All will be enrolled at M D Anderson
Before treatment starts patients will have a complete medical history and a brief physical exam Researchers will ask about alopecia disease history date of first diagnosis and earlier treatments and responses Blood test about 4 teaspoons will be performed before and after the end of treatment Additional blood tests will be done if needed Women able to have children must have a negative blood pregnancy test within 7 days before the start of treatment Blood pregnancy test must be repeated once a month while receiving treatment
Participants in this study will be randomly assigned as in the toss of a coin to treat alopecia areata lesions on only one half of their head Half of the participants will have the left side treated while the other half will have the right side treated Sealed envelopes will be given to participants telling them which side of the head to treat The other half of the head will remain untreated and serve as the control
Patients will treat alopecia lesions on one-half of the head including facial hair as designated by the investigator The other half of the head will have control untreated alopecia lesions Up to 5 index lesions for treatment and 5 control lesions will be designated at baseline to follow and measure during the study Patients will be treated with Targretin gel 1 in a dose escalation regimen starting at once every day At the start of Week 3 patients will begin applications of twice a day applications if tolerated Patients will continue BID dosing if tolerated unless the investigator determines a further increase in application frequency may benefit the patient and the patient agrees to comply
Patients will be seen at baseline and at weeks 2 4 8 12 16 20 24 and at a 4-week follow-up Telephone evaluations will be done at week 1 and as needed
Study visits for evaluation of safety and efficacy will be made at Week 2 and 4 after the start of treatment and then every 4 weeks up until Week 24 Telephone safety evaluations will also be made at Week 1 and other times as needed
Skin irritation or changes in health during the study may require participants to stop treatment or withdraw from the study
At withdrawal from the study about 4 teaspoons of blood will be drawn The total study duration is 24 Weeks with a 4-week follow-up period At the 4-week follow-up visit a physical exam including measurement of vital signs and weight will be performed An evaluation of both treated and untreated sides of the head will be performed
Patients who show a response at 6 months 24 weeks will be given the option to continue therapy for an additional 6 months and will be able to apply the medication to both sides of the head Patients will come every 2 months 3 additional visits and will have the same examination as they have had during the study with evaluation of irritation hair loss hair thickness measurement of lesions and the physicians global assessment which is the evaluation of hair re-growth The same dose adjustment and withdrawal from treatment will be applied during this 6-month period Every 2 months blood about 2 tablespoons will be drawn for pregnancy tests and to look at your triglycerides fat levels and complete blood cell counts
This is an investigational study Targretin Gel 1 is commercially available and approved by the FDA for use in the treatment of cutaneous lesions in patients with CTCL Initially up to 42 participants will be enrolled in the study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None