Female Pattern AlopeciaNCT01292746
Study of the Effect of Low Level Laser Light on Hair Growth on the Female Human Scalp
A study testing Erchonia MLS in people with Female Pattern Alopecia, run by Erchonia Corporation at 1 site in United States.
Trial summary
The purpose of this clinical study is to determine if the Erchonia® ML Scanner (MLS) low level laser light device can help to regrow hair on the scalp of females experiencing hair loss or thinning. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Female Pattern Alopecia
- What is being tested?
- Erchonia MLS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female pattern androgenic alopecia defined as:
- discernable decrease in hair density on the top of the scalp relative to the sides and back of the scalp (ii) classifications I-3, I-4, II-1, II-2 according to the Ludwig and Savin Hair Loss Scale
- Notable hair loss/thinning onset within the past five years.
- Progressive/active hair loss/thinning within the last 12 months.
- Skin type I through IV according to the Fitzpatrick Skin Type Scale.
- Healthy, balanced scalp, determined as one that shows no indication of notable: dryness, flaking, dandruff (pityriasis), redness, irritation, inflammation, itching, greasy/oily texture, odor, lesions, scalp acne or other significant dermatological conditions.
- PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status Classification System.
- Willing and able to maintain same hair style, length, color and hair care regimen throughout study participation.
Who cannot join
- Hair loss attributable to one or more of the following conditions: tinea capsitis, secondary syphilis, discoid lupus erythematosus: Inflammation, alopecia areata, trichotillomania, telogen effluvium, anagen effluvium, traumatic alopecia.
- Use of any of the following medications presently or during the prior 6 months: minoxidil, finasteride (or any other 5ᾳ-reductase inhibitor medications),medication with anti-androgenic properties (e.g. cyproterone, spironolactone, ketoconazole, flutamide and bicalutamide),topical estrogens, progesterone, tamoxifen, anabolic steroids, medications that can potentially cause hypertrichosis (e.g. ciclosporin, diazoxide, phenytoin and psoralens), oral glucocorticoids (inhaled glucocorticoids permitted), lithium, phenothiazines.
- Current use of other prescription and/or over-the-counter products known to affect hair growth and distribution (e.g. saw palmetto, fish oil, corticosteroids, antineoplastic agents, beta blockers, diazoxide, heparin, verapamil, warfarin, etc.).
- Medical, physical, or other contraindications for, or sensitivity to, light therapy (e.g. porphyria, photosensitizing drug therapies).
- Taking Hormonal Replacement Therapy.
- Conditions that may worsen with light therapy.
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- History of poor wound healing.
- History of keloid formation.
- Prior hair restoration/transplantation surgery.
- Prior scalp reduction procedure(s).
- Other surgery to the scalp region (e.g. to remove a skin cancer lesion).
- Active skin infection, wound, or other external trauma to the scalp evaluation area.
- Active malignancy or any malignancy in the past five years in the scalp evaluation area.
- Dermatological condition (dermatitis, eczema, psoriasis, etc.) of the scalp other than female pattern hair loss.
- Significant scarring (e.g. from burns) in the scalp evaluation area.
- History of thyroid condition that may influence hair growth and loss.
- Underlying medical condition(s) known to adversely affect hair growth or hair pattern, such as HIV, connective tissue disease, inflammatory bowel disease.
- Current hair weaves.
- Use of non-breathable wigs.
- Hairstyle is a "buzz" cut, defined as hair cut to less than one inch in length.
- Tattooing of the scalp target evaluation area.
- Subject is pregnant, nursing, planning a pregnancy, or less than six months postpartum.
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to record study measurements.
- Involvement in litigation/receiving disability benefits related in any way to the parameters of the study.
- Participation in research in the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Gynecology Specialists of Georgia
Evans, Georgia, 30809
About this study
Official title: An Evaluation of the Effect of the Erchonia ML Scanner (MLS) on the Treatment of Androgenic Alopecia in Females
The purpose of this clinical study is to determine if the Erchonia® ML Scanner (MLS) low level laser light device can help to regrow hair on the scalp of females experiencing hair loss or thinning.
Read the detailed description
Over 20 million women in the United States suffer from hair loss, and about 40% of those women are under forty years of age. The emotional aspects of hair loss for females include anxiety and depression, frustration and poor self-esteem. Androgenetic alopecia is a common cause of female balding and the most likely reason for excessive hair loss.
It is believed that light therapy of the scalp will provide an effective means to reduce hair loss and/or stimulate hair growth in females with androgenetic alopecia. Results of previous studies on low level laser therapy (LLLT) have demonstrated a variety of in vitro and in vivo effects including increased blood flow, accelerated wound healing, enhanced production of cytokines and other cellular mediators, increased cellular proliferation, among a panoply of other effects. Enhanced hair growth has been observed adjacent to treated areas in various animal models investigating the effects of LLLT. Uncontrolled studies in humans and spa-based therapies in Europe appear to show that the periodic application of low intensity light therapy reduces hair loss and appears to increase hair growth. The majority of these applications utilize light in the red and near-infrared portions of the spectrum.
The Erchonia MLS low level laser is being evaluated for its potential to improve the quality and quantity of hair on the female scalp. This may improve the quality of life as a result of improved self-image and may potentially delay or reduce the need for surgical procedures such as hair transplantation. A successful local therapy would mitigate or reduce the need for systemic agents such as minoxidil and finasteride, thereby minimizing the potential side effects of these therapies.
- Conditions
- Female Pattern Alopecia
- Being tested
- Erchonia MLS
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia MLSDevice
The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia ML Scanner (MLS) | Experimental | Erchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light Receives: Device: Erchonia MLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area
Non-vellus terminal hair count was calculated across a tattooed 3 cm diameter scalp area from digital photographs of the area by independent blinded evaluator employing macroimage analysis software.
Measured: Baseline and 13 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Recruitment and subject study compliance was difficult
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Female Pattern AlopeciaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul M Thaxton, MD, FACOG, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292746
- Sponsor's protocol ID
- EC_FA001
- Status last verified
- Nov 2015
- First submitted
- 8 Feb 2011
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of the Erchonia ML Scanner (MLS) on the Treatment of Androgenic Alopecia in Females
- ClinicalTrials.gov ID
- NCT01292746
- Acronym / sponsor ID
- EC_FA001
- Conditions
- Female Pattern Alopecia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment and subject study compliance was difficult
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Posted 11 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to determine if the Erchonia® ML Scanner (MLS) low level laser light device can help to regrow hair on the scalp of females experiencing hair loss or thinning.
Detailed description
Over 20 million women in the United States suffer from hair loss, and about 40% of those women are under forty years of age. The emotional aspects of hair loss for females include anxiety and depression, frustration and poor self-esteem. Androgenetic alopecia is a common cause of female balding and the most likely reason for excessive hair loss.
It is believed that light therapy of the scalp will provide an effective means to reduce hair loss and/or stimulate hair growth in females with androgenetic alopecia. Results of previous studies on low level laser therapy (LLLT) have demonstrated a variety of in vitro and in vivo effects including increased blood flow, accelerated wound healing, enhanced production of cytokines and other cellular mediators, increased cellular proliferation, among a panoply of other effects. Enhanced hair growth has been observed adjacent to treated areas in various animal models investigating the effects of LLLT. Uncontrolled studies in humans and spa-based therapies in Europe appear to show that the periodic application of low intensity light therapy reduces hair loss and appears to increase hair growth. The majority of these applications utilize light in the red and near-infrared portions of the spectrum.
The Erchonia MLS low level laser is being evaluated for its potential to improve the quality and quantity of hair on the female scalp. This may improve the quality of life as a result of improved self-image and may potentially delay or reduce the need for surgical procedures such as hair transplantation. A successful local therapy would mitigate or reduce the need for systemic agents such as minoxidil and finasteride, thereby minimizing the potential side effects of these therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erchonia ML Scanner (MLS) | Experimental | Device: Erchonia MLSErchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female pattern androgenic alopecia defined as:
- Notable hair loss/thinning onset within the past five years.
- Progressive/active hair loss/thinning within the last 12 months.
- Skin type I through IV according to the Fitzpatrick Skin Type Scale.
- Healthy, balanced scalp, determined as one that shows no indication of notable: dryness, flaking, dandruff (pityriasis), redness, irritation, inflammation, itching, greasy/oily texture, odor, lesions, scalp acne or other significant dermatological conditions.
Key exclusion criteria (26 listed)
- Hair loss attributable to one or more of the following conditions: tinea capsitis, secondary syphilis, discoid lupus erythematosus: Inflammation, alopecia areata, trichotillomania, telogen effluvium, anagen effluvium, traumatic alopecia.
- Use of any of the following medications presently or during the prior 6 months: minoxidil, finasteride (or any other 5ᾳ-reductase inhibitor medications),medication with anti-androgenic properties (e.g. cyproterone, spironolactone, ketoconazole, flutamide and bicalutamide),topical estrogens, progesterone, tamoxifen, anabolic steroids, medications that can potentially cause hypertrichosis (e.g. ciclosporin, diazoxide, phenytoin and psoralens), oral glucocorticoids (inhaled glucocorticoids permitted), lithium, phenothiazines.
- Current use of other prescription and/or over-the-counter products known to affect hair growth and distribution (e.g. saw palmetto, fish oil, corticosteroids, antineoplastic agents, beta blockers, diazoxide, heparin, verapamil, warfarin, etc.).
- Medical, physical, or other contraindications for, or sensitivity to, light therapy (e.g. porphyria, photosensitizing drug therapies).
- Taking Hormonal Replacement Therapy.
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 |
|---|---|---|
| Erchonia MLSThe Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments. | Device | Erchonia ML Scanner (MLS) |
Primary outcome
Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area
Time frame: Baseline and 13 Weeks
Non-vellus terminal hair count was calculated across a tattooed 3 cm diameter scalp area from digital photographs of the area by independent blinded evaluator employing macroimage analysis software.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul M Thaxton, MD, FACOG principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia MLS in people with Female Pattern Alopecia, run by Erchonia Corporation 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 8 inclusion and 26 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: stopped early, as of the sponsor's last update on 11 Dec 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area (time frame: Baseline and 13 Weeks). 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 11 Dec 2015.