Safety and Efficacy Study for Various Skin Conditions

Not Applicable

Completed

• Conditions: Photodamaged Skin; Dyschromia
• Interventions: Device: HALO

• Registration Number: NCT02693054
• Lead Sponsor: Sciton

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.

Study Timeline

• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Study Start: 2016-04
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hybrid Fractional Laser Treatment	HALO	Halo (1470nm and 2940 nm) laser

Primary Outcome Measures

Name	Time	Method
Improvement in skin conditions assessed by photographs	6 months	Assessment of photographs by blinded evaluators

Secondary Outcome Measures

Name	Time	Method
Subject satisfaction post final treatment	3 months	Assessment of subject satisfaction with treatment result using survey/questionnaire