Safety and Efficacy Study for Various Skin Conditions | NCT02693054

Studies
Safety and Efficacy Study for Various Skin Conditions

NCT02693054

Sponsor

Sciton

Status

Completed

Last Update Posted

Apr 18, 2018Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Dyschromia
Photodamaged Skin

Interventions

HALO

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Feb 8, 2016

First Submission Date that Met QC Criteria

Feb 22, 2016

First Posted Date

Feb 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2018

Last Update Posted Date

Apr 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Label	Type	Description	Intervention Names
Hybrid Fractional Laser Treatment	Experimental	Halo (1470nm and 2940 nm) laser	Device: HALO

Name	Type	Description	Arm Group Labels	Other Names
HALO	Device	Laser Treatment	Hybrid Fractional Laser Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
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