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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Ligand Pharmaceuticals |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00063076 |
Purpose
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:
| Condition | Intervention | Phase |
|---|---|---|
|
Alopecia Areata |
Drug: Targretin Gel 1% |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata |
| Enrollment: | 46 |
| Study Start Date: | May 2003 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Targretin®: Experimental
Targretin® (bexarotene) Gel 1%, treat half head
|
Drug: Targretin Gel 1%
Alopecia lesions on one-half of the head including facial hair treated, and other half on head serves as control (untreated). Starting dose once every day till Week 3 then escalate to twice a day.
|
|
Control: No Intervention
Half head untreated as control
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Madeleine Duvic, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Madeleine Duvic, MD / Professor ) |
| Study ID Numbers: | DM02-164 |
| Study First Received: | June 19, 2003 |
| Last Updated: | October 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00063076 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Alopecia Areata Alopecia Totalis Alopecia Universalis Targretin Gel |
|
Hair Diseases Pathological Conditions, Anatomical Anticarcinogenic Agents Hypotrichosis Skin Diseases Antineoplastic Agents Physiological Effects of Drugs |
Protective Agents Pharmacologic Actions Alopecia Areata Bexarotene Alopecia Therapeutic Uses |