Safety and Efficacy Study for Various Skin Conditions

Characterizing Safety and Efficacy of Halo Hybrid Fractional Laser Treatments for Various Skin Conditions

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

Study Overview

• Status: Completed
• Conditions: Dyschromia; Photodamaged Skin
• Intervention / Treatment: Device: HALO

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid Fractional Laser Treatment; Halo (1470nm and 2940 nm) laser	Device: HALO; Laser Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in skin conditions assessed by photographs	Assessment of photographs by blinded evaluators	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject satisfaction post final treatment	Assessment of subject satisfaction with treatment result using survey/questionnaire	3 months

Collaborators and Investigators

• Sponsor: Sciton
• Investigators: Principal Investigator: Jason Pozner, MD, Sanctuary Plastic Surgery; Principal Investigator: Christopher Robb, MD, Skin and Allergy Center; Principal Investigator: Elizabeth Tanzi, MD, Capital Laser and Skin Care; Principal Investigator: Jill Waibel, MD, Miami Dermatology and Laser Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 8, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: HALOCIP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No