Clinical Evaluation of Hair Removal and Permanent Hair Reduction for Skin Types VI Using Intense Pulsed Light
Stopped early · Not applicable
Conditions studied: Removal of Excess or Unwanted Body Hair
In brief
This is a Multi-center, blinded, baseline-controlled, prospective study to evaluate permanent hair reduction and removal for skin types V and VI using IPL.
Key facts
- Study ID
- NCT02452398
- Run by
- Venus Concept
- People needed
- 79
- Starts
- 2015-01-01
- Expected to finish
- 2017-04-18
- Last updated by the study team
- 2020-11-03
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Able to read, understand and provide written Informed Consent;
- Subject has black or dark brown terminal hairs in the areas to be treated.
- Terminal hair density requirement of greater than 15 hairs within the hair count site (3x3 cm area) as determined by manual hair count performed by the study investigator.
- Healthy adult, male or female, 21 years of age or older with skin type V-VI;
- Having a suitable treatment area for hair removal;
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.
You may not qualify if…
- Subject has light ,gray terminal or fine hairs in all/some parts of the treated area;
- Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
- Hormonal disorders that may affect hair growth;
- Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
- Livedo reticularis;
- Uncontrolled systemic diseases such as diabetes;
- Active infections in the treated area;
- Dysplastic nevi;
- Significant concurrent skin conditions or any inflammatory skin conditions;
- Active cold sores, open lacerations or abrasions;
- Chronic or cutaneous viral, fungal, or bacterial diseases;
- Current cancer;
- History of skin cancer or pre-cancerous lesions at the treatment areas;
- Use of Accutane™ (Isotretinoin) within the past six month;
- Keloid or Hypertrophic scar formation in the treatment area;
- Tattoos in the treatment area;
- Bleeding coagulopathies or use of anticoagulants;
- Auto-immune disorders;
- Erythema abigne, when identified treatments should be discontinued;
- Photosensitivity disorder that can be exacerbated by laser or intense light;
- Herpes simplex in the treatment area;
- Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;
- Poor wound healing;
- Sunburns;
- Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a month) and during the course of the evaluation;
Where it is running
- Dermatology and Laser Centre — Manhattan Beach, California, United States
Full record on ClinicalTrials.gov
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