A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata
18 Years
N/A
Both
Alopecia Areata
Trial Information
A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata
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 physician's 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.
Inclusion Criteria:
1. Clinical diagnosis of alopecia areata, alopecia totalis, or alopecia universalis.
2. Patients must be 18 years of age to participate.
3. Patients with alopecia areata must have at least two distinct alopecia areata patches
>1.0 cm diameter, one located on the right and left sides each of the scalp. Patients
with alopecia totalis or universalis will not have distinct alopecia patches but will
have complete or total alopecia on both the sides of the scalp. Patients with
alopecia totalis or universalis will have one side of the scalp treated. The patient
must agree to treat only one side of the scalp with drug, to have photos taken, and
to return for follow-up visits.
4. They must also agree to practice two reliable forms of contraception (hormonal, IUD,
double barrier) to be used simultaneously unless abstinence is the chosen method
during the entire period of treatment and for at least one month after treatment is
discontinued.
5. Men with sexual partners who are of childbearing potential or pregnant must use
condoms during sexual intercourse during Targretin® gel therapy and for one month
after the last application.
6. Patients will be asked to voluntarily contribute pre- and post biopsies for research
studies (3 mm punch biopsies for hematoxylin and eosin (H&E) staining and
immunohistochemistry of T-cells). However, failure to consent to biopsies will not
exclude them from the study.
7. Patients have signed the informed consent.
Exclusion Criteria:
1. Must be off other topical treatment for alopecia areata or PUVA (psoralen + UVA)
therapy for at least two weeks.
2. Must have discontinued intralesional steroids or any systemic therapies that are
immunosuppressive or that may affect alopecia areata for at least four weeks.
Patients who are on chronic oral steroids are not eligible for the study.
3. Women who are pregnant or breastfeeding are excluded. The pregnancy test will be
sensitive to at least 25 mlU/ml.
4. Patients with hepatitis, HIV or other serious infections are excluded.
5. Known hypersensitivity to Targretin® drug or to any retinoid or to any ingredient in
the study medication.
6. Patients must not have participated in any other investigational drug study within 4
weeks of entry.
7. Patients with Hbg < 9.5 g/dL, WBC < 2,500 K/ul, Platelets < 100 K/ul, TSH > 5.5 or <
0.5 mcU/mL, T4 < 0.9 or > 1.8 g/dl, or fasting triglyceride level > 350 mg/dl will
not be eligible to participate in the study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response and toxicity of Targretin Gel 1% treatment for alopecia areata
Outcome Description:
"Response" defined as hair growth at PGA grade 3 or 4, and "toxicity" as vesiculation grade 3 or ulceration at grade 4 using design of Thall, Simon and Estey (1995, 1996). To monitor response and toxicity, four possible elementary outcomes are: 1 = [no toxicity, no response], 2 = [no toxicity, response], 3 = [toxicity, no response] , 4 = [toxicity, response].
Outcome Time Frame:
Baseline and at weeks 2,4,8,12,16,20,24 and at a 4-week follow-up
Safety Issue:
Yes
Principal Investigator
Madeleine Duvic, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
DM02-164
NCT ID:
NCT00063076
Start Date:
May 2003
Completion Date:
May 2007
Related Keywords:
- Alopecia Areata
- Alopecia Areata
- Alopecia Totalis
- Alopecia Universalis
- Targretin Gel
- Alopecia
- Alopecia Areata
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
