Pilot Study of a Novel IPL for Removal of Unwanted Fine Body Hair (NCT01912950) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study of a Novel IPL for Removal of Unwanted Fine Body Hair
United States11 participantsStarted 2013-12
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Must be in good health, as determined by the Investigator.
* Must be post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.
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 h…
What they're measuring
1
Comparison of Percent Hair Reduction Between Treatment Arm and Non-treated Control Arm at 12 Weeks Post Final Treatment