Clinical trial NCT02693054: Safety and Efficacy Study for Various Skin Conditions
Official title: Characterizing Safety and Efficacy of Halo Hybrid Fractional Laser Treatments for Various Skin Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyschromia
Photodamaged Skin
Lead sponsor: Sciton
Sponsor class: INDUSTRY
First posted: 2016-02-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Characterizing safety and efficacy of Halo Laser Treatment for Various Skin Conditions.

Detailed description: The purpose of this study is to demonstrate safety and efficacy of Halo treatment as measured by changes in skin tone, texture and pigment.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in skin conditions assessed by photographs
timeFrame: 6 months
Secondary outcomes:
measure: Subject satisfaction post final treatment
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Sanctuary Plastic Surgery
name: Jason Pozner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin and Allergy Center
name: Christopher Robb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Laser and Skin Care
name: Elizabeth Tanzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami Dermatology and Laser Institute
name: Jill Waibel, MD
role: PRINCIPAL_INVESTIGATOR
References: