24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness

NCT01686295 | Unknown

• 1 other identifier: CS940112
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

androgenetic alopecia; Baldness

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

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

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

Device: sham device

Interventions

iRestore Hair Rejuvenation System DEVICE

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

iRestore Hair Rejuvenation System

sham device 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

Also known as: iRestore Hair Rejovenation System

Sham Device Arm

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Freedom Laser Therapy, Inc.: lead
• TKL Research, Inc.: collaborator

Study Sites (1)

TKL Research Inc.

Paramus, New Jersey, 07652, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Dosik, MD

  TKL Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: September 18, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 18, 2012

Record last verified: 2012-09

Locations

US (1)