AlopeciaNCT03331003
"iRestore" Light Therapy Apparatus
A study testing low level light therapy and non-LLLT wavelength group in people with Alopecia, run by National Taiwan University Hospital.
Trial summary
Current effective therapies of pattern hiar loss are topical minoxidil and oral finasteride. Finasteride is an inhibitor of type 2 5α-reductase and will cause hypospadias in male infant if taken or touched by pregnant woman. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia
- What is being tested?
- low level light therapy and non-LLLT wavelength group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2015to 15 Dec 2016
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects of either gender who are 25-60 years old.
- The male-pattern alopecia in men belongs to Stages IIa-V of the Norwood-Hamilton Scale;
- The male-pattern alopecia in women belongs to Stages I-4, II-1 and II-2 of the Ludwig (Savin) Scale.
- The subjects shall agree to have temporary punctate tattoo at the observed part.
- There was continuous hair loss during the past 12 months.
- Women with fertility shall agree to adopt appropriate contraception measures, including the intrauterine device, condom, spermicide, abstinence, vasoligation of the sexual partner, etc.
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- The skin type ranges between Types I and IV of Fitzpatrick scale, as shown in Table 1.
- The subjects agree to shave off the hair at the observed part.
- The photographic release form shall be read carefully before the signature.
- The informed consent form shall be read carefully to understand the detailed trial content and the signature shall be made without any disturbance.
- Table 1. Fitzpatrick Skin Typing
- Always burns, never tans
- Usually burns, tans minimally
- Frequently burns and tans (light brown)
- Rarely burns, tans easily (brown)
- Very rarely burns, tans very easily (brown)
- Never burns (dark brown to black)
Who cannot join
- Use or administration of the following drugs within 6 months before the recruitment:
- Minoxidil, finasteride or other inhibitors of 5α-reductase;
- The drugs that may inhibit androgen, such as cyproterone, spironolactone, ketoconazole, flutamide and bicalutamide.
- The drugs that may cause hirsutism, such as ciclosporin, diazoxide, phenytoin, Propecia, Dutasteride and psoralens, or other drugs for treating prostatic hypertrophy.
- Oral adrenal corticoid (except inhaler adrenal corticoid)
- The drugs with possible phototoxicity, such as tetracyclins, thiazides and certain NSAIDS.
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- Lithium or antischizophrenic drugs (phenothiazines);
- Any drugs that will influence the assessment results or subjects' safety according to the opinions of the principal investigator.
- Anti-cancer drugs.
- Pregnant or breastfeeding women or those plan to get pregnant during the trial. The women with fertility shall take the contraceptive drugs orally or have the implantation, injection or subcutaneous injection of contraceptive drugs.
- Patients with Type 2 diabetes.
- Patients with heart disease who take phototoxic drugs.
- Those who don't agree to maintain the hairstyle and hair color during the trial.
- Those who had hair transplantation, scalp reconstruction procedure, hair braiding or scalp tattoo, which will influence the assessment results of the test or the subjects' safety according to the opinions of the principal investigator.
- Those who use or once used depilation agents, laser hair removal or beeswax on the scalp to remove the hair or perform any action which will influence the assessment results of the trial according to the opinions of the principal investigator.
- There is psoriasis, dermatitis, eczema or severe acne on the scalp.
- Those who suffer from the diseases which may influence the hair growth according to the opinions of the principal investigator, such as the immunodeficiency syndrome, connective tissue-related diseases or infectious baldness.
- Those with insignificant contrast of scalp and hair color, such as light skin color or white hair.
- Inability to cooperate with the trial: those subjects who can't use the device or pay a return visit periodically according to the instruction of the physician or hospital during the trial in the opinions of the principal investigator.
About this study
Official title: "iRestore" Light Therapy Apparatus in the Treatment of Androgenetic Alopecia: A Randomized, Double-blind, Self-comparison, Sham Device-controlled, Multicenter Trial
Current effective therapies of pattern hiar loss are topical minoxidil and oral finasteride. Finasteride is an inhibitor of type 2 5α-reductase and will cause hypospadias in male infant if taken or touched by pregnant woman. The effect of minoxidil is still known now but the dilation of scalp vessel might improve the progression of pattern hair oss. However, minoxidil is not effective for frontotemporal recession and sometimes cause scalp irritation.
Low-level laser therapy (LLLT) a new therapy to treat alopecia. In 2007, LLLT was approved by the FDA as a treatment for hair loss. In some small studies, patients had a decrease in the number of vellus hairs, an increase in the number of terminal hairs, and an increase in shaft diameter. Up to now, however, no longer, placebo-controlled studies have proved its efficacy in this application.
Read more
According to the mechanism of paradoxical hair growth (PHG), sublethal injury to the hair follicle could stimulate the hair follicle to enter anagen via the release of factors that alter angiogenesis, leading to increased blood flow to the dermal papilla. Furthermore, load inflammation in the papilla nad heat shok response, possibly mediated by HSP27, may play a role in activation of follicular stem cell.
This study is a randomized, blinded, self-comparison and superior clinical trial design. In this clinical trial, the investigators try to evaluate the efficacy of low-level laser therapy in treating pattern hair loss. Pattern hair loss is characterized by increased vellus hairs and decreased shaft diameter, and these features are improved by LLLT in previous.
Read the detailed description
This study is A randomized, double-blind, self-comparison, sham device- controlled, multicenter Trial. Total subjects is 100 and the clinical trial was conducted in National Taiwan University Hospital and National Taiwan University Hospital-Hsinchu Branch. The study starts from December 2013 to June 2015 for within 18 months.
The potential subjects will be collected into the clinical study, and have 24 weeks of treatment. The forth, twelve and twenty-fourth weeks are took as evaluation point. Besides the photo shooting area, recording the density of hair growth, analyzing of hair growth number, and the width of hair will be quantified. At the same time, the subject will also have the safety evaluation to see if there are any reddish or skin disorder(erythema, edema, dried, skin keratinization) or other systematic symptom. After quantifying the data, the degree of covered area in target area is seen as primary end point.
- Conditions
- Alopecia
- Being tested
- low level light therapy, non-LLLT wavelength group
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level light therapyDevice
iRestore low-level light therapy on androgenetic alopecia
non-LLLT wavelength groupDevice
A LED light device is non-curative for the patients.
| Study group | Role | What they receive |
|---|---|---|
| low level light therapy | Experimental | 1 group uses the investigational device on the left side, and the subjects will have half part receiving low level light therapy (red light-emitting diode and laser irradiation) Receives: Device: low level light therapy |
| non-LLLT wavelength group group | Placebo comparator | the control device on the right side, other half with non-low-level laser therapy wavelength (white light-emitting diode light bulb coating with red paint to make the irradiating light close to the red). Receives: Device: non-LLLT wavelength group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair coverage of the targeted area
The photomicrography is taken to record the hair growth in the target area. The Folliscope (IBS-01 Pro Beauty Scope, Kowa Optics Corp.) is used to record the hair coverage in the tattooed area and analyze the hair growth number. The photography of the global scalp is also taken to record the top scalp and hair line shapes of the subjects. Hair coverage equals to ∑_(i=1)^n*π R_i^2
Measured: In the 24th week
Secondary outcomes (12)
evaluate the hair coverage
The Paired-T or McNemar's test is adopted to evaluate the hair coverage in the 4th and 12th weeks.
Measured: in the 4th and 12th weeks
evaluate the increased hair thickness of the targeted area
The Paired-T test is adopted to evaluate the increased hair thickness of the targeted area
Measured: in the 4th, 12th and 24th weeks
number of the hair in the targeted area
The Paired-T test is adopted to evaluate the number of the hair in the targeted area.
Measured: in the 4th, 12th and 24th weeks
global assessment of the hair growth condition
The principal investigator will carry out the global assessment of the hair growth condition. The Wilcoxon rank sum test is adopted for comparison and the line chart is used to demonstrate the trend of the treatment effect. The scores of global assessment of the hair growth condition is 1, and 1 refers to thin.
Measured: in the 4th, 12th and 24th weeks
global assessment of the hair growth condition
The principal investigator will carry out the global assessment of the hair growth condition. The Wilcoxon rank sum test is adopted for comparison and the line chart is used to demonstrate the trend of the treatment effect. The scores of global assessment of the hair growth condition is 3, and three refers to dense.
Measured: in the 4th, 12th and 24th weeks
global assessment of the hair growth condition
The principal investigator will carry out the global assessment of the hair growth condition. The Wilcoxon rank sum test is adopted for comparison and the line chart is used to demonstrate the trend of the treatment effect. The scores of global assessment of the hair growth condition is 2, and 2 refers to medium, and three refers to dense.
Measured: in the 4th, 12th and 24th weeks
global assessment of the hair growth condition
The principal investigator will carry out the global assessment of the hair growth condition. The Wilcoxon rank sum test is adopted for comparison and the line chart is used to demonstrate the trend of the treatment effect. The scores of global assessment of the hair growth condition is 0, and 0 refers to no hair growth.
Measured: in the 4th, 12th and 24th weeks
The subjects' overall satisfaction assessment
The subjects' overall satisfaction assessment shall be carried out. The Wilcoxon rank sum test is adopted for comparison and the line chart is used to demonstrate the trend of the treatment effect.
The scores of subject's satisfaction is 0 refers to dissatisfy.
Measured: in the 4th, 12th and 24th weeks
The subjects' overall satisfaction assessment
The subjects' overall satisfaction assessment shall be carried out. The Wilcoxon rank sum test is adopted for comparison and the line chart is used to demonstrate the trend of the treatment effect.
The scores of subject's satisfaction is 1 that refers to slightly satisfy.
Measured: in the 4th, 12th and 24th weeks
The subjects' overall satisfaction assessment
The subjects' overall satisfaction assessment shall be carried out. The Wilcoxon rank sum test is adopted for comparison and the line chart is used to demonstrate the trend of the treatment effect.
The scores of subject's satisfaction is 2 that refers to moderately satisfy.
Measured: in the 4th, 12th and 24th weeks
The subjects' overall satisfaction assessment
The subjects' overall satisfaction assessment shall be carried out. The Wilcoxon rank sum test is adopted for comparison and the line chart is used to demonstrate the trend of the treatment effect.
The scores of subject's satisfaction is 3 that refers to satisfy.
Measured: in the 4th, 12th and 24th weeks
The subjects' overall satisfaction assessment
The subjects' overall satisfaction assessment shall be carried out. The Wilcoxon rank sum test is adopted for comparison and the line chart is used to demonstrate the trend of the treatment effect.
The scores of subject's satisfaction is 4 that refers to Highly satisfy.
Measured: in the 4th, 12th and 24th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start30 Mar 2015
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331003
- Sponsor's protocol ID
- 201310067DSB
- Status last verified
- Mar 2014
- First submitted
- 18 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "iRestore" Light Therapy Apparatus in the Treatment of Androgenetic Alopecia: A Randomized, Double-blind, Self-comparison, Sham Device-controlled, Multicenter Trial
- ClinicalTrials.gov ID
- NCT03331003
- Acronym / sponsor ID
- 201310067DSB
- Conditions
- Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
Current effective therapies of pattern hiar loss are topical minoxidil and oral finasteride. Finasteride is an inhibitor of type 2 5α-reductase and will cause hypospadias in male infant if taken or touched by pregnant woman. The effect of minoxidil is still known now but the dilation of scalp vessel might improve the progression of pattern hair oss. However, minoxidil is not effective for frontotemporal recession and sometimes cause scalp irritation.
Low-level laser therapy (LLLT) a new therapy to treat alopecia. In 2007, LLLT was approved by the FDA as a treatment for hair loss. In some small studies, patients had a decrease in the number of vellus hairs, an increase in the number of terminal hairs, and an increase in shaft diameter. Up to now, however, no longer, placebo-controlled studies have proved its efficacy in this application.
According to the mechanism of paradoxical hair growth (PHG), sublethal injury to the hair follicle could stimulate the hair follicle to enter anagen via the release of factors that alter angiogenesis, leading to increased blood flow to the dermal papilla. Furthermore, load inflammation in the papilla nad heat shok response, possibly mediated by HSP27, may play a role in activation of follicular stem cell.
This study is a randomized, blinded, self-comparison and superior clinical trial design. In this clinical trial, the investigators try to evaluate the efficacy of low-level laser therapy in treating pattern hair loss. Pattern hair loss is characterized by increased vellus hairs and decreased shaft diameter, and these features are improved by LLLT in previous.
Detailed description
This study is A randomized, double-blind, self-comparison, sham device- controlled, multicenter Trial. Total subjects is 100 and the clinical trial was conducted in National Taiwan University Hospital and National Taiwan University Hospital-Hsinchu Branch. The study starts from December 2013 to June 2015 for within 18 months.
The potential subjects will be collected into the clinical study, and have 24 weeks of treatment. The forth, twelve and twenty-fourth weeks are took as evaluation point. Besides the photo shooting area, recording the density of hair growth, analyzing of hair growth number, and the width of hair will be quantified. At the same time, the subject will also have the safety evaluation to see if there are any reddish or skin disorder(erythema, edema, dried, skin keratinization) or other systematic symptom. After quantifying the data, the degree of covered area in target area is seen as primary end point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low level light therapy | Experimental | Device: low level light therapy1 group uses the investigational device on the left side, and the subjects will have half part receiving low level light therapy (red light-emitting diode and laser irradiation) |
| non-LLLT wavelength group group | Placebo comparator | Device: non-LLLT wavelength groupthe control device on the right side, other half with non-low-level laser therapy wavelength (white light-emitting diode light bulb coating with red paint to make the irradiating light close to the red). |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- The subjects of either gender who are 25-60 years old.
- The male-pattern alopecia in men belongs to Stages IIa-V of the Norwood-Hamilton Scale;
- The male-pattern alopecia in women belongs to Stages I-4, II-1 and II-2 of the Ludwig (Savin) Scale.
- The subjects shall agree to have temporary punctate tattoo at the observed part.
- There was continuous hair loss during the past 12 months.
Key exclusion criteria (19 listed)
- Use or administration of the following drugs within 6 months before the recruitment:
- Pregnant or breastfeeding women or those plan to get pregnant during the trial. The women with fertility shall take the contraceptive drugs orally or have the implantation, injection or subcutaneous injection of contraceptive drugs.
- Patients with Type 2 diabetes.
- Patients with heart disease who take phototoxic drugs.
- Those who don't agree to maintain the hairstyle and hair color during the trial.
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 |
|---|---|---|
| low level light therapyiRestore low-level light therapy on androgenetic alopecia | Device | low level light therapy |
| non-LLLT wavelength groupA LED light device is non-curative for the patients. | Device | non-LLLT wavelength group group |
Primary outcome
Hair coverage of the targeted area
Time frame: In the 24th week
The photomicrography is taken to record the hair growth in the target area. The Folliscope (IBS-01 Pro Beauty Scope, Kowa Optics Corp.) is used to record the hair coverage in the tattooed area and analyze the hair growth number. The photography of the global scalp is also taken to record the top scalp and hair line shapes of the subjects. Hair coverage equals to ∑_(i=1)^n*π R_i^2
12 secondary outcomes
evaluate the hair coverage
Time frame: in the 4th and 12th weeks
evaluate the increased hair thickness of the targeted area
Time frame: in the 4th, 12th and 24th weeks
number of the hair in the targeted area
Time frame: in the 4th, 12th and 24th weeks
global assessment of the hair growth condition
Time frame: in the 4th, 12th and 24th weeks
global assessment of the hair growth condition
Time frame: in the 4th, 12th and 24th weeks
global assessment of the hair growth condition
Time frame: in the 4th, 12th and 24th weeks
global assessment of the hair growth condition
Time frame: in the 4th, 12th and 24th weeks
The subjects' overall satisfaction assessment
Time frame: in the 4th, 12th and 24th weeks
The subjects' overall satisfaction assessment
Time frame: in the 4th, 12th and 24th weeks
The subjects' overall satisfaction assessment
Time frame: in the 4th, 12th and 24th weeks
The subjects' overall satisfaction assessment
Time frame: in the 4th, 12th and 24th weeks
The subjects' overall satisfaction assessment
Time frame: in the 4th, 12th and 24th weeks
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 6 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing low level light therapy and non-LLLT wavelength group in people with Alopecia, run by National Taiwan University Hospital.
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 17 inclusion and 19 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Hair coverage of the targeted area (time frame: In the 24th week). 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 6 Nov 2017.