Alopecia AreataNCT01736007
Childhood Alopecia Areata Study Using the 308-nm Excimer Laser
A study testing 308-nm excimer laser to alopecia patch and Liquid light guide tip on laser in people with Alopecia Areata, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
Alopecia Areata (AA) is a skin restricted autoimmune disease of the hair follicle, resulting in hair loss of the scalp, and in severe cases of the entire body. AA is the second most common cause of alopecia in childhood; no FDA-approved treatments exist. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- 308-nm excimer laser to alopecia patch and Liquid light guide tip on laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2014
- Phase
- Interventional
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 6-17 years old, diagnosed with patch type alopecia areata for a minimum of 6 months prior to enrollment involving the scalp.
- A Parent/guardian consent and child assent (in those 8 years old or greater) must be obtained.
- Parent/guardian and patient agree to MED dose test with a 24 hour follow up visit and a 12 week period of twice weekly treatment in either group, as well as baseline, interim and end of study visits.
- Parent/guardian and child must be able to understand English or Spanish to participate.
- Parent/guardian must agree to have the patient undergo a washout period of 6 weeks prior to the enrollment of the study if the patient is currently on treatment of any kind (oral and/or topical) for AA.
Who cannot join
- Children who have been diagnosed with an autoimmune skin disease or photosensitivity disorder.
- Children who have been using topical steroids to the scalp, have other scalp disease or are using injected or oral steroids, biologic agents or chemotherapy for other medical conditions.
- Children under current treatment for other skin conditions with oral medications (such as an oral corticosteroid) and/or topical treatments such as topical corticosteroids that may affect hair regrowth. Specifically, for topical medications, any child that requires the use of class 1-2 topical corticosteroids will be excluded.
- 3. Any subject who is currently experiencing significant spontaneous regrowth of terminal hair.
- 4. Patients with alopecia universalis, totalis, ophiasis pattern or diffuse AA may not participate in this feasibility study.
- 4. Parent/guardian who do not consent or children who do not assent to participate.
- 5. Any subject who has had AA for less than 6 months and is not willing to undergo a 6 week wash-out period prior to start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Childhood Alopecia Areata Study: Part 1: Feasibility of the 308-nm Excimer Laser in Treatment of Patch Type Alopecia Areata in Pediatric Patients
Alopecia Areata (AA) is a skin restricted autoimmune disease of the hair follicle, resulting in hair loss of the scalp, and in severe cases of the entire body. AA is the second most common cause of alopecia in childhood; no FDA-approved treatments exist. The use of focused narrow-band ultraviolet-B light via the excimer laser is a common treatment for many skin diseases in patients of all ages. In this study, the feasibility of the 308-nm excimer laser for treatment of patch type AA of the scalp will be examined. We anticipate the excimer laser will be safe and a feasible option for patients with patch type AA. The excimer laser may represent a novel treatment for childhood AA and no comparison or large studies currently exist in the literature.
Hypotheses The 308-nm excimer laser procedure is a feasible, well-tolerated and safe treatment for patch type alopecia areata of the scalp in children.
Read the detailed description
The goal of this study is to assess the feasibility, safety and response to treatment of the use of the 308-nm excimer laser in children (age 6-17 years) diagnosed with patch type alopecia areata involving the scalp, present for more than 6 months duration. Patients meeting the inclusion criteria will be randomly enrolled in a treatment group or placebo group. Response to treatment during and after the 12-week laser treatment course will be measured in terms of hair regrowth utilizing the SALT score and 2 blinded evaluations of subject photographs.
Specific Aims Evaluate the feasibility and safety of twice-weekly excimer laser treatments over a period of 12 weeks. Measures will include side effects, response to treatment (hair growth), tolerability of therapy, attrition, attendance, and overall satisfaction with this treatment modality.
- Conditions
- Alopecia Areata
- Being tested
- 308-nm excimer laser to alopecia patch, Liquid light guide tip on laser
- Keywords
- alopecia areata child, scalp
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
308-nm excimer laser to alopecia patchDevice
Also called PhotoMedex XTRAC XL Excimer Laser System, Model AL 8000
MED dosing as per protocol with beginning at 50 mJ/cm2 below MED with increases by 50mJ/cm2 every 2 treatments as tolerated. Maximum dosing would be 850mJ.Treatments given twice a week for 12 weeks.
Liquid light guide tip on laserDevice
Also called Liquid light guide tip applied to Excimer laser
Sham treatment involves placement of liquid light guide tip developed by the laser company which attaches to the end of the hand wand and blocks the laser light from passing to the target. Patients are treated twice a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Liquid light guide tip on laser | Sham comparator | Excimer laser treatment with 308-nm excimer laser with guide tip applied to alopecia patch twice a week. Receives: Device: Liquid light guide tip on laser |
| 308-nm excimer laser to alopecia patch | Active comparator | Laser treatment with 308-nm excimer laser procedure to alopecia patch twice a week with increasing fluence as tolerated. Receives: Device: 308-nm excimer laser to alopecia patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The goal of this study is to assess the feasibility, safety and response to treatment of the use of the 308-nm excimer laser in children diagnosed with patch type alopecia areata involving the scalp, present for more than 6 months duration
Response to treatment during and after the 12-week laser treatment course will be measured in terms of hair regrowth utilizing the SALT score and 2 blinded evaluations of subject photographs. Follow up post treatment at 36 weeks and 48 weeks.
Measured: 9 months
Secondary outcomes (1)
Evaluate the feasibility and safety of twice-weekly excimer laser treatments over a period of 12 weeks
Measures will include side effects, response to treatment (hair growth), tolerability of therapy, attrition, attendance, and overall satisfaction with this treatment modality.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013 (estimated)
- Study completionAug 2014 (estimated)
Why it stopped: was not able to recruit participants
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harper N Price, MD, Principal investigator, Phoenix Children's HospitalJudith AJ O'Haver, PhD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736007
- Sponsor's protocol ID
- PCH-derm001
- Other IDs
- IDE Number: G110232/S2
- Status last verified
- Oct 2014
- First submitted
- 1 Nov 2012
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Alopecia Areata Study: Part 1: Feasibility of the 308-nm Excimer Laser in Treatment of Patch Type Alopecia Areata in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01736007
- Acronym / sponsor ID
- PCH-derm001
- Conditions
- Alopecia Areata
- Keywords
- alopecia areata child, scalp
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: was not able to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 28 Nov 2012 (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.
Alopecia Areata (AA) is a skin restricted autoimmune disease of the hair follicle, resulting in hair loss of the scalp, and in severe cases of the entire body. AA is the second most common cause of alopecia in childhood; no FDA-approved treatments exist. The use of focused narrow-band ultraviolet-B light via the excimer laser is a common treatment for many skin diseases in patients of all ages. In this study, the feasibility of the 308-nm excimer laser for treatment of patch type AA of the scalp will be examined. We anticipate the excimer laser will be safe and a feasible option for patients with patch type AA. The excimer laser may represent a novel treatment for childhood AA and no comparison or large studies currently exist in the literature.
Hypotheses The 308-nm excimer laser procedure is a feasible, well-tolerated and safe treatment for patch type alopecia areata of the scalp in children.
Detailed description
The goal of this study is to assess the feasibility, safety and response to treatment of the use of the 308-nm excimer laser in children (age 6-17 years) diagnosed with patch type alopecia areata involving the scalp, present for more than 6 months duration. Patients meeting the inclusion criteria will be randomly enrolled in a treatment group or placebo group. Response to treatment during and after the 12-week laser treatment course will be measured in terms of hair regrowth utilizing the SALT score and 2 blinded evaluations of subject photographs.
Specific Aims Evaluate the feasibility and safety of twice-weekly excimer laser treatments over a period of 12 weeks. Measures will include side effects, response to treatment (hair growth), tolerability of therapy, attrition, attendance, and overall satisfaction with this treatment modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid light guide tip on laser | Sham comparator | Device: Liquid light guide tip on laserExcimer laser treatment with 308-nm excimer laser with guide tip applied to alopecia patch twice a week. |
| 308-nm excimer laser to alopecia patch | Active comparator | Device: 308-nm excimer laser to alopecia patchLaser treatment with 308-nm excimer laser procedure to alopecia patch twice a week with increasing fluence as tolerated. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children 6-17 years old, diagnosed with patch type alopecia areata for a minimum of 6 months prior to enrollment involving the scalp.
- A Parent/guardian consent and child assent (in those 8 years old or greater) must be obtained.
- Parent/guardian and patient agree to MED dose test with a 24 hour follow up visit and a 12 week period of twice weekly treatment in either group, as well as baseline, interim and end of study visits.
- Parent/guardian and child must be able to understand English or Spanish to participate.
- Parent/guardian must agree to have the patient undergo a washout period of 6 weeks prior to the enrollment of the study if the patient is currently on treatment of any kind (oral and/or topical) for AA.
Key exclusion criteria (7 listed)
- Children who have been diagnosed with an autoimmune skin disease or photosensitivity disorder.
- Children who have been using topical steroids to the scalp, have other scalp disease or are using injected or oral steroids, biologic agents or chemotherapy for other medical conditions.
- Children under current treatment for other skin conditions with oral medications (such as an oral corticosteroid) and/or topical treatments such as topical corticosteroids that may affect hair regrowth. Specifically, for topical medications, any child that requires the use of class 1-2 topical corticosteroids will be excluded.
- 3. Any subject who is currently experiencing significant spontaneous regrowth of terminal hair.
- 4. Patients with alopecia universalis, totalis, ophiasis pattern or diffuse AA may not participate in this feasibility study.
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 |
|---|---|---|
| 308-nm excimer laser to alopecia patchAlso: PhotoMedex XTRAC XL Excimer Laser System, Model AL 8000MED dosing as per protocol with beginning at 50 mJ/cm2 below MED with increases by 50mJ/cm2 every 2 treatments as tolerated. Maximum dosing would be 850mJ.Treatments given twice a week for 12 weeks. | Device | 308-nm excimer laser to alopecia patch |
| Liquid light guide tip on laserAlso: Liquid light guide tip applied to Excimer laserSham treatment involves placement of liquid light guide tip developed by the laser company which attaches to the end of the hand wand and blocks the laser light from passing to the target. Patients are treated twice a week for 12 weeks. | Device | Liquid light guide tip on laser |
Primary outcome
The goal of this study is to assess the feasibility, safety and response to treatment of the use of the 308-nm excimer laser in children diagnosed with patch type alopecia areata involving the scalp, present for more than 6 months duration
Time frame: 9 months
Response to treatment during and after the 12-week laser treatment course will be measured in terms of hair regrowth utilizing the SALT score and 2 blinded evaluations of subject photographs. Follow up post treatment at 36 weeks and 48 weeks.
1 secondary outcome
Evaluate the feasibility and safety of twice-weekly excimer laser treatments over a period of 12 weeks
Time frame: 48 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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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.
Harper N Price, MD principal investigator
Phoenix Children's Hospital
Judith AJ O'Haver, PhD principal investigator
Phoenix Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 308-nm excimer laser to alopecia patch and Liquid light guide tip on laser in people with Alopecia Areata, run by Phoenix Children's Hospital 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 5 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: withdrawn, as of the sponsor's last update on 31 Oct 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The goal of this study is to assess the feasibility, safety and response to treatment of the use of the 308-nm excimer laser in children diagnosed with patch type alopecia areata involving the scalp, present for more than 6 months duration (time frame: 9 months). 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 31 Oct 2014.