Alopecia AreataPhase 2/3NCT00063076
Phase II Randomized Bilateral Comparison of Topical Targretin Gel 1% in Alopecia Areata
A Phase 2/3 study testing Targretin Gel 1% in people with Alopecia Areata, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Targretin Gel 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to May 2007
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of alopecia areata, alopecia totalis, or alopecia universalis.
- Patients must be 18 years of age to participate.
- 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.
- 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.
- 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.
- 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.
- Patients have signed the informed consent.
Who cannot join
- Must be off other topical treatment for alopecia areata or PUVA (psoralen + UVA) therapy for at least two weeks.
- 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.
- Women who are pregnant or breastfeeding are excluded. The pregnancy test will be sensitive to at least 25 mlU/ml.
- Patients with hepatitis, HIV or other serious infections are excluded.
- Known hypersensitivity to Targretin® drug or to any retinoid or to any ingredient in the study medication.
- Patients must not have participated in any other investigational drug study within 4 weeks of entry.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata
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:
- Determine the safety and tolerability of Targretin® Gel 1% in the treatment of patients with alopecia areata.
- Determine the efficacy of Targretin® Gel 1% in the treatment of patients with alopecia areata.
Read the 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 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.
- Conditions
- Alopecia Areata
- Being tested
- Targretin Gel 1%
- Keywords
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Targretin Gel
- Medical subject headings
- Alopecia Areata, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targretin Gel 1%Drug
Also called Targretin
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.
| Study group | Role | What they receive |
|---|---|---|
| Targretin® | Experimental | Targretin® (bexarotene) Gel 1%, treat half head Receives: Drug: Targretin Gel 1% |
| Control | No intervention | Half head untreated as control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response and toxicity of Targretin Gel 1% treatment for alopecia areata
"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].
Measured: Baseline and at weeks 2,4,8,12,16,20,24 and at a 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2003 (estimated)
- Study startMay 2003
- Primary completionOct 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ligand Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Madeleine Duvic, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063076
- Sponsor's protocol ID
- DM02-164
- Status last verified
- Aug 2012
- First submitted
- 19 Jun 2003
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata
- ClinicalTrials.gov ID
- NCT00063076
- Acronym / sponsor ID
- DM02-164
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Targretin Gel
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Ligand Pharmaceuticals
- Study start
- May 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 20 Jun 2003 (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 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:
- Determine the safety and tolerability of Targretin® Gel 1% in the treatment of patients with alopecia areata.
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targretin® | Experimental | Drug: Targretin Gel 1%Targretin® (bexarotene) Gel 1%, treat half head |
| Control | No intervention | –Half head untreated as control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of alopecia areata, alopecia totalis, or alopecia universalis.
- Patients must be 18 years of age to participate.
- 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.
- 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.
- 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.
Key exclusion criteria (7 listed)
- Must be off other topical treatment for alopecia areata or PUVA (psoralen + UVA) therapy for at least two weeks.
- 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.
- Women who are pregnant or breastfeeding are excluded. The pregnancy test will be sensitive to at least 25 mlU/ml.
- Patients with hepatitis, HIV or other serious infections are excluded.
- Known hypersensitivity to Targretin® drug or to any retinoid or to any ingredient in the study medication.
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 |
|---|---|---|
| Targretin Gel 1%Also: TargretinAlopecia 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. | Drug | Targretin® |
Primary outcome
Response and toxicity of Targretin Gel 1% treatment for alopecia areata
Time frame: Baseline and at weeks 2,4,8,12,16,20,24 and at a 4-week follow-up
"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].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Madeleine Duvic, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Targretin Gel 1% in people with Alopecia Areata, run by M.D. Anderson Cancer Center at 1 site in United States.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response and toxicity of Targretin Gel 1% treatment for alopecia areata (time frame: Baseline and at weeks 2,4,8,12,16,20,24 and at a 4-week follow-up). 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 2 Aug 2012.