Photodamaged Skin Clinical Trial
Official title:
Characterizing Safety and Efficacy of Halo Hybrid Fractional Laser Treatments for Various Skin Conditions
Verified date | April 2018 |
Source | Sciton |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Fitzpatrick Skin types I to IV - Desires improvement of significant skin conditions on the face and/or neck - Willingness to participate in the study by signing an informed consent form - Will have limited sun exposure for at least two weeks prior to study screening and during the study, including the follow-up period - Able to adhere to the treatment and follow-up schedule and post-treatment care instructions - Post-menopausal or surgically sterilized female subjects. Exclusion Criteria: - History of Halo or resurfacing procedures in the treatment area within past six months - Has tanned within the past thirty days or unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray, or cream - Has tattoos, dysplastic nevi in the treatment area - Pregnant and/or lactating - Is planning to get pregnant within the study period - Has a known history of photosensitivity - Has used medication with photosensitizing properties within the past six months, e.g. isotretinoin - History or evidence of chronic or recurring skin disease or disorder (e.g. psoriasis, --Netherton syndrome, etc.) affecting the treatment area - Has open lacerations, abrasions, active cold sores, or herpes sores - Has hormonal disorders - History of keloid or hypertrophic scar formation or poor wound healing - History of immunosuppression or immune deficiency disorder (including HIV infection or AIDS) or use of immunosuppressive medications - History of bleeding disorder or taking anticoagulation medications - History of skin cancer or any other cancer in the treatment area - Has significant concurrent illnesses, such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment - Has participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past thirty days - The investigator feels that for any reason the subject is not eligible to participate in the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sciton |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in skin conditions assessed by photographs | Assessment of photographs by blinded evaluators | 6 months | |
Secondary | Subject satisfaction post final treatment | Assessment of subject satisfaction with treatment result using survey/questionnaire | 3 months |
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