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Safety and Efficacy Study for Various Skin Conditions

Sponsor
Sciton (Industry)
Overall Status
Completed
CT.gov ID
NCT02693054
Collaborator
(none)
34
Enrollment
1
Arm
8
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: HALO
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Characterizing Safety and Efficacy of Halo Hybrid Fractional Laser Treatments for Various Skin Conditions
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hybrid Fractional Laser Treatment

Halo (1470nm and 2940 nm) laser

Device: HALO
Laser Treatment

Outcome Measures

Primary Outcome Measures

  1. Improvement in skin conditions assessed by photographs [6 months]

    Assessment of photographs by blinded evaluators

Secondary Outcome Measures

  1. Subject satisfaction post final treatment [3 months]

    Assessment of subject satisfaction with treatment result using survey/questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sciton
ClinicalTrials.gov Identifier:
NCT02693054
Other Study ID Numbers:
  • HALOCIP001
First Posted:
Feb 26, 2016
Last Update Posted:
Apr 18, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Skin Diseases

Study Results

No Results Posted as of Apr 18, 2018