Recruiting

Hair Growth System

Sponsor:

Freedom Laser Therapy, Inc.

Code:

NCT01686295

Conditions

Androgenetic Alopecia

Eligibility Criteria

Sex: All

Age: 25 - 60

Healthy Volunteers: Accepted

Interventions

iRestore Hair Rejuvenation System

sham device

Study Details

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

Conditions

Androgenetic Alopecia

Study ID

NCT01686295

Start date

Jul, 2012

Status verified date

Sep, 2012

Completion date

May, 2013

Anticipated

Primary completion date

Apr, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: iRestore Hair Rejuvenation System

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

sham comparator: Sham Device Arm

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

Interventions

iRestore Hair Rejuvenation System

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 device

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

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 ]

Central Contacts and Locations

Locations

TKL Research Inc.

Recruiting

Paramus, New Jersey, United States, 07652

Contacts

Principal Investigator:

Jonathan Dosik, M.D.

More Information

Sponsor

Freedom Laser Therapy, Inc.

Last update posted

Sep 18, 2012

Last verified

Sep, 2012

Keywords

  • androgenetic alopecia
  • Baldness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Freedom Laser Therapy, Inc. on 2012-09-18.