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Safety and Efficacy Study for Various Skin Conditions

Primary Purpose

Dyschromia, Photodamaged Skin

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

HALO

About this trial

This is an interventional other trial for Dyschromia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hybrid Fractional Laser Treatment

Arm Description

Halo (1470nm and 2940 nm) laser

Outcomes

Primary Outcome Measures

Improvement in skin conditions assessed by photographs

Assessment of photographs by blinded evaluators

Secondary Outcome Measures

Subject satisfaction post final treatment

Assessment of subject satisfaction with treatment result using survey/questionnaire

Full Information

NCT ID

NCT02693054

First Posted

February 8, 2016

Last Updated

April 16, 2018

Sponsor

Sciton

1. Study Identification

Unique Protocol Identification Number

NCT02693054

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sciton

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyschromia, Photodamaged Skin

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hybrid Fractional Laser Treatment

Arm Type

Experimental

Arm Description

Halo (1470nm and 2940 nm) laser

Intervention Type

Device

Intervention Name(s)

HALO

Intervention Description

Laser Treatment

Primary Outcome Measure Information:

Title

Improvement in skin conditions assessed by photographs

Description

Assessment of photographs by blinded evaluators

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Subject satisfaction post final treatment

Description

Assessment of subject satisfaction with treatment result using survey/questionnaire

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason Pozner, MD

Organizational Affiliation

Sanctuary Plastic Surgery

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christopher Robb, MD

Organizational Affiliation

Skin and Allergy Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Elizabeth Tanzi, MD

Organizational Affiliation

Capital Laser and Skin Care

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jill Waibel, MD

Organizational Affiliation

Miami Dermatology and Laser Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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Safety and Efficacy Study for Various Skin Conditions

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