Safety and Efficacy Study for Various Skin Conditions

NCT02693054 | Completed

• 1 other identifier: HALOCIP001
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dyschromia; Photodamaged Skin

Outcome Measures

Primary Outcomes (1)

• Improvement in skin conditions assessed by photographs

  Assessment of photographs by blinded evaluators

  6 months

Secondary Outcomes (1)

• Subject satisfaction post final treatment

  3 months

Study Arms (1)

Hybrid Fractional Laser Treatment

EXPERIMENTAL

Halo (1470nm and 2940 nm) laser

Device: HALO

Interventions

HALO DEVICE

Laser Treatment

Hybrid Fractional Laser Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sciton: lead

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 26, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share