Safety and Efficacy Study for Various Skin Conditions

Photodamaged Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693054
• Other study ID #: HALOCIP001
• Status: Completed
• Phase: N/A
• First received: February 8, 2016
• Last updated: April 16, 2018
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2018
• Source: Sciton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyschromia
• Photodamaged Skin
• Skin Diseases

Intervention

Device:
• HALO
Laser Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sciton

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in skin conditions assessed by photographs	Assessment of photographs by blinded evaluators	6 months
Secondary	Subject satisfaction post final treatment	Assessment of subject satisfaction with treatment result using survey/questionnaire	3 months