Brief Title
24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness
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
Brief 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
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 Type
Interventional
Primary Outcome
Change from Screening/Baseline Hair Growth at Week 12 and Week 24
Secondary Outcome
Visual Scalp Assessment
Condition
Androgenetic Alopecia
Intervention
iRestore Hair Rejuvenation System
Study Arms / Comparison Groups
iRestore Hair Rejuvenation System
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
100
Start Date
July 2012
Completion Date
May 2013
Primary Completion Date
April 2013
Eligibility Criteria
Inclusion Criteria:
- Individuals eligible for inclusion in the study are those who:
1. Are male or female, 25 to 60 years of age;
2. If male, have Norwood-Hamilton classifications of IIa to V male pattern baldness;
3. If female, have Ludwig Scale classifications I-4, II-1, II-2, or frontal;
4. Are willing to have a tattoo created on the target area;
5. Have been experiencing active hair loss within the last 12 months;
6. 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);
7. Have Fitzpatrick Skin Type I-IV (See Table 1 Below);
8. Are willing to have the target area hair clipped;
9. Read, understand, and sign a photographic release form(s); and
10. 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
Exclusion Criteria:
- Individuals excluded from participation in the study are those who:
1. 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);
- 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;
2. Will not agree to refrain from changing hair color and hair style during the
course of the study;
3. 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;
4. 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;
5. Have psoriasis, active dermatitis/eczema, or severe acne on the scalp area;
6. Have diabetes requiring exogenous insulin;
7. Have cataracts;
8. 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);
9. 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;
10. Are females who are pregnant, planning to become pregnant during the study, or
breastfeeding; and/or
11. Are, in the opinion of the investigative personnel, unable to comprehend and/or
otherwise comply with any aspect of study requirements.
Gender
All
Ages
25 Years - 60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jonathan Dosik, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01686295
Organization ID
CS940112
Secondary IDs
CS940112
Responsible Party
Sponsor
Study Sponsor
Freedom Laser Therapy, Inc.
Collaborators
TKL Research, Inc.
Study Sponsor
Jonathan Dosik, MD, Principal Investigator, TKL Research, Inc.
Verification Date
September 2012