A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal (NCT02536092) | Clinical Trial Compass
WithdrawnNot Applicable
A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal
Stopped: Sponsor terminated study
Canada0Started 2015-09
Plain-language summary
To evaluate the safety and efficacy of the Cutera excel HR dual wavelength 755nm Alexandrite and 1064nm Nd:YAG laser for hair removal.
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 - VI (Appendix 3).
* Subject has black or dark brown unwanted hair.
* Subject must be able to read, understand and sign the Informed Consent Form.
* Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
* Willing to refrain from shaving the treatment area for 5 days prior to each study visit.
* Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
* 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).
* Be in good health, as determined by the Investigator.
* 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 hair removal procedure, such as laser, light-based, RF or electrolysis, in the treatment area within 12 months of study participation.
* Had o…