Androgenetic AlopeciaNCT01686295
24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness
A study testing iRestore Hair Rejuvenation System in people with Androgenetic Alopecia, run by Freedom Laser Therapy, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of the iRestore Hair Rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- iRestore Hair Rejuvenation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2013
- 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
- Individuals eligible for inclusion in the study are those who:
- Are male or female, 25 to 60 years of age;
- If male, have Norwood-Hamilton classifications of IIa to V male pattern baldness;
- If female, have Ludwig Scale classifications I-4, II-1, II-2, or frontal;
- Are willing to have a tattoo created on the target area;
- Have been experiencing active hair loss within the last 12 months;
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- In the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence or partner's vasectomy: abstinence or partner's vasectomy are acceptable if the female agrees to implement one of the other acceptable methods of birth control if her lifestyle or partner changes);
- Have Fitzpatrick Skin Type I-IV (See Table 1 Below);
- Are willing to have the target area hair clipped;
- Read, understand, and sign a photographic release form(s); and
- Read, understand, and sign an informed consent document after being advised of the nature of the study.
- Table 1: Fitzpatrick Skin Types I Always burns easily, never tans II Always burns easily, tans minimally III Burns moderately, tans gradually (light brown) IV Burns minimally, always tans well (moderate brown) V Rarely burns, tans very well (moderate brown) VI Never burn, deeply pigmented
Who cannot join
- Individuals excluded from participation in the study are those who:
- Have used any of the following medications within 6 months prior to enrollment:
- minoxidil, finasteride (or any other 5α-reductase inhibitor medications);
- medications with anti-androgenic properties (eg, cyproterone, spironolactone, ketoconazole, flutamide, and bicalutamide);
- topical estrogens, progesterone, tamoxifen, anabolic steroids;
- medications that can potentially cause hypertrichosis (eg, ciclosporin, diazoxide, phenytoin, and psoralens);
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- oral glucocorticoids (inhaled glucocorticoids are permitted);
- lithium or phenothiazines;
- medications of known or suspected phototoxicity (eg, tetracyclines, thiazides, certain NSAIDs);
- other medications which, in the opinion of the investigator, may interfere with the performance of study assessments or place the subject at undue risk;
- Will not agree to refrain from changing hair color and hair style during the course of the study;
- Have had a hair transplant, scalp reduction, hair weave, or tattoo which, in the opinion of the investigator, may interfere with the performance of the study assessments;
- Are using or have used depilatories, razors, or wax on the scalp to an extent which, in the opinion of the investigator, may interfere with the performance of the study assessments;
- Have psoriasis, active dermatitis/eczema, or severe acne on the scalp area;
- Have diabetes requiring exogenous insulin;
- Have cataracts;
- Have any medical condition which, in the opinion of the investigator, could affect hair growth (eg, Human Immunodeficiency Virus, connective tissue disease, inflammatory bowel disease);
- Have very little contrast between hair color and scalp, eg, are of a fair hair color (eg, white or very blond) and have very pale skin;
- Are females who are pregnant, planning to become pregnant during the study, or breastfeeding; and/or
- Are, in the opinion of the investigative personnel, unable to comprehend and/or otherwise comply with any aspect of study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
TKL Research Inc.
Paramus, New Jersey, 07652
C Andresen, 201-587-0808, candresen@tklresearch.com
Jonathan Dosik, M.D.
About this study
Official title: A Randomized, Double -Blind,, Sham-Device-Controlled, Multicenter, 24-Week Clinical Trial to Evaluate the Safety and Effectiveness of the iRestore ™ Hair Rejuvenation System in the Treatment of Male and Female Androgeneticalopecia
The purpose of this study is to evaluate the effectiveness of the iRestore Hair Rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia
Read the detailed description
The test treatment is the iRestore™ Hair Rejuvenation System. The device irradiates the scalp with visible light using 5 mW (class 3a) lasers. It is to be used approximately 3 times per week for approximately 30 minutes at each session.
The System is placed on the head and adjusted to a comfortable size by rotating knobs on the side of the device. If needed, subjects may replace the soft pad on the inside of the device with the thinner pad provided. There will be 2 options for using the product. The subject will either insert the 5-V AC power adapter pin into the device remote control, and the 5-V adapter will then be plugged into the AC outlet; or the subjects will use the rechargeable battery pack and belt clip. The battery pack is an external device which will allow the subject the freedom of mobility while treating the hair. The rechargeable battery pack will hold a charge for up to 3 hours prior to needing to be recharged. The iRestore™ remote control clips into the battery holster and the pack plugs into the remote. The battery pack can be placed in a pocket, clipped to the belt or placed next to the subject. The device will be turned on by pressing the power button on the remote control. The dome of the device is to be moved forward and backward by the subject to brush through the hair and increase the direct light which comes into contact with the scalp. Subjects will then position the dome at the front of the scalp and press the start button to begin a 10-minute session. Note: As a safety feature, the dome must be placed onto the head prior to starting the device. A timer will indicate the completion of the session with a beep sound. Subjects will complete the same process as done with the front of the scalp with the dome repositioned to the middle of the scalp and then the back of the scalp. Once all 3 positions have received the 10 minute treatment, the power button is to be held for approximately 3 seconds to turn the device off. Once off the device is to be unplugged from the wall.
The control device will be identical to the test device except that the laser-emitting units will be disabled. A standard light will be emitted from the device. Subjects and clinical staff engaged in the performance of assessments will be treatment blinded.
- Conditions
- Androgenetic Alopecia
- Being tested
- iRestore Hair Rejuvenation System, sham device
- Keywords
- androgenetic alopecia, Baldness
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iRestore Hair Rejuvenation SystemDevice
This study is to evaluate the effectiveness of the iRestore Hair Rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days
sham deviceDevice
Also called iRestore Hair Rejovenation System
This shame device will be a sham comparator to evaluate the effectiveness of the iRestore Hair rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days
| Study group | Role | What they receive |
|---|---|---|
| iRestore Hair Rejuvenation System | Experimental | Seventy six (76) subjects will be enrolled in the 24-week study; of which 38 will be male and 38 will be female using the iRestore hair growth device Receives: Device: iRestore Hair Rejuvenation System |
| Sham Device Arm | Sham comparator | This study arm will use a sham device consistent with the experimental device with 12 men and 12 women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days Receives: Device: sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Screening/Baseline Hair Growth at Week 12 and Week 24
Standardized global scalp photographs will be taken of each subject prior to hair clipping for hair count macrophotography. These photographs will be obtained at Screening/Baseline, Week 12, and Week 24.To determine any differences from baseline photos.
- Frontal (male only) and Top Scalp Views (female only): Hair will be center-parted and combed away from the part.
- Vertex View (male only): Hair will be combed away from the center of the vertex like the spokes of a wheel.
Global scalp photographs will be sent to Canfield Scientific, Inc. a central core lab for study imaging.
Measured: Screening/Baseline, Week 12, and Week 24. The hair will be clean and properly combed for each individual in the following manner
Secondary outcomes (1)
Visual Scalp Assessment
At Baseline, Week 4, Week 12, and Week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee for any sign of irritation or dermatologic conditions (eg, erythema, edema, dryness, scaling). The grading scale provided in Table 5 will be used to categorize each condition:
Table 5: Visual Scalp Assessment Scale SCORE RESPONSE 0 None
- Mild
- Moderate
- Severe
Measured: At Baseline, Week 4, Week 12, and Week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Freedom Laser Therapy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Jonathan Dosik, MD, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686295
- Sponsor's protocol ID
- CS940112
- Other IDs
- CS940112
- Status last verified
- Sep 2012
- First submitted
- 10 Aug 2012
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double -Blind,, Sham-Device-Controlled, Multicenter, 24-Week Clinical Trial to Evaluate the Safety and Effectiveness of the iRestore ™ Hair Rejuvenation System in the Treatment of Male and Female Androgeneticalopecia
- ClinicalTrials.gov ID
- NCT01686295
- Acronym / sponsor ID
- CS940112
- Conditions
- Androgenetic Alopecia
- Keywords
- androgenetic alopecia, Baldness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Freedom Laser Therapy, Inc.Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 18 Sep 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.
The purpose of this study is to evaluate the effectiveness of the iRestore Hair Rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia
Detailed description
The test treatment is the iRestore™ Hair Rejuvenation System. The device irradiates the scalp with visible light using 5 mW (class 3a) lasers. It is to be used approximately 3 times per week for approximately 30 minutes at each session.
The System is placed on the head and adjusted to a comfortable size by rotating knobs on the side of the device. If needed, subjects may replace the soft pad on the inside of the device with the thinner pad provided. There will be 2 options for using the product. The subject will either insert the 5-V AC power adapter pin into the device remote control, and the 5-V adapter will then be plugged into the AC outlet; or the subjects will use the rechargeable battery pack and belt clip. The battery pack is an external device which will allow the subject the freedom of mobility while treating the hair. The rechargeable battery pack will hold a charge for up to 3 hours prior to needing to be recharged. The iRestore™ remote control clips into the battery holster and the pack plugs into the remote. The battery pack can be placed in a pocket, clipped to the belt or placed next to the subject. The device will be turned on by pressing the power button on the remote control. The dome of the device is to be moved forward and backward by the subject to brush through the hair and increase the direct light which comes into contact with the scalp. Subjects will then position the dome at the front of the scalp and press the start button to begin a 10-minute session. Note: As a safety feature, the dome must be placed onto the head prior to starting the device. A timer will indicate the completion of the session with a beep sound. Subjects will complete the same process as done with the front of the scalp with the dome repositioned to the middle of the scalp and then the back of the scalp. Once all 3 positions have received the 10 minute treatment, the power button is to be held for approximately 3 seconds to turn the device off. Once off the device is to be unplugged from the wall.
The control device will be identical to the test device except that the laser-emitting units will be disabled. A standard light will be emitted from the device. Subjects and clinical staff engaged in the performance of assessments will be treatment blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iRestore Hair Rejuvenation System | Experimental | Device: iRestore Hair Rejuvenation SystemSeventy six (76) subjects will be enrolled in the 24-week study; of which 38 will be male and 38 will be female using the iRestore hair growth device |
| Sham Device Arm | Sham comparator | Device: sham deviceThis study arm will use a sham device consistent with the experimental device with 12 men and 12 women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Individuals eligible for inclusion in the study are those who:
- Table 1: Fitzpatrick Skin Types I Always burns easily, never tans II Always burns easily, tans minimally III Burns moderately, tans gradually (light brown) IV Burns minimally, always tans well (moderate brown) V Rarely burns, tans very well (moderate brown) VI Never burn, deeply pigmented
Key exclusion criteria (20 listed)
- Individuals excluded from participation in the study are those who:
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 |
|---|---|---|
| iRestore Hair Rejuvenation SystemThis study is to evaluate the effectiveness of the iRestore Hair Rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days | Device | iRestore Hair Rejuvenation System |
| sham deviceAlso: iRestore Hair Rejovenation SystemThis shame device will be a sham comparator to evaluate the effectiveness of the iRestore Hair rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days | Device | Sham Device Arm |
Primary outcome
Change from Screening/Baseline Hair Growth at Week 12 and Week 24
Time frame: Screening/Baseline, Week 12, and Week 24. The hair will be clean and properly combed for each individual in the following manner
Standardized global scalp photographs will be taken of each subject prior to hair clipping for hair count macrophotography. These photographs will be obtained at Screening/Baseline, Week 12, and Week 24.To determine any differences from baseline photos. * Frontal (male only) and Top Scalp Views (female only): Hair will be center-parted and combed away from the part. * Vertex View (male only): Hair will be combed away from the center of the vertex like the spokes of a wheel. Global scalp photographs will be sent to Canfield Scientific, Inc. a central core lab for study imaging.
1 secondary outcome
Visual Scalp Assessment
Time frame: At Baseline, Week 4, Week 12, and Week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
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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.
Jonathan Dosik, MD principal investigator
TKL Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iRestore Hair Rejuvenation System in people with Androgenetic Alopecia, run by Freedom Laser Therapy, Inc. 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 12 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 18 Sep 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Screening/Baseline Hair Growth at Week 12 and Week 24 (time frame: Screening/Baseline, Week 12, and Week 24. The hair will be clean and properly combed for each individual in the following manner). 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 18 Sep 2012; AzTrials last refreshed its copy on 6 Nov 2026.