Randomized, Controlled, Open-Label Pilot Study of a Novel IPL for Removal of Unwanted Fine Hair

Cutera Inc.1 site in 1 country11 target enrollmentDecember 2013

ConditionsHypertrichosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hypertrichosis
Sponsor: Cutera Inc.
Enrollment: 11
Locations: 1
Primary Endpoint: Comparison of Percent Hair Reduction Between Treatment Arm and Non-treated Control Arm at 12 Weeks Post Final Treatment
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this randomized, controlled, open-label pilot study is to evaluate the safety and efficacy of a novel intense pulsed light (IPL) device for removal of unwanted fine body hair.

Subjects will have IPL treatment on one forearm area. Another area will serve as the un-treated control area. Subjects will be followed at 12-weeks post-final treatment.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

July 2015

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cutera Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female or Male, 18 to 65 years of age (inclusive).
•Fitzpatrick Skin Type I - III.
•Subject has black or dark brown unwanted arm hair of fine texture.
•Willing to have the hair removal procedure on one forearm only, and within the designated study treatment area.
•Willing and able to adhere to the treatment and follow-up schedule, and the study "Before and After Procedure Instructions".
•Willing to refrain from shaving the treatment area for 5 days prior to each study visit.
•Must be able to read, understand and sign the Informed Consent Form.
•Must agree not to use hair removal products, such as topical chemical depilatories, or undergo any other hair removal procedure during the study, such as other laser and light therapies or waxing.
•Willing to refrain from excess sun exposure and willing to wear sunscreen on the treatment area during the study (including the follow-up period).
•Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.

Exclusion Criteria

•Participation in a clinical trial of another device or drug within 6 months prior to enrollment, or during the study.
•Had any type of professional hair removal procedure, such as laser, light-based, RF or electrolysis, in the treatment area within 12 months of study participation.
•Had other epilation treatment, such as waxing or mechanical epilator, in the treatment area within 6 months of study participation.
•Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study.
•Subject is pregnant and/or breastfeeding.
•Suffering from significant concurrent illness, such as diabetes mellitus or pertinent neurological disorders.
•Having malignant or pre-malignant lesions in the treatment area, or history of a malignant skin disease.
•Current acute or chronic skin infections or inflammatory processes, affecting the treatment area, such as dermatitis.
•Currently using immunosuppressive medications or history of immunosuppression/immune deficiency disorder, such as psoriasis, eczema, vitiligo, systemic lupus erythematosus or scleroderma.
•Current use of any medication that is known to increase sensitivity to light, such as tetracycline.