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Safety and Efficacy Study for Various Skin Conditions | Clinical Trials | Clareo Health

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Safety and Efficacy Study for Various Skin Conditions

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

NCT02693054•Sciton

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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
+6 more criteria

Key Dates

Start Date

April 1, 2016

Primary Completion Date

December 1, 2016

Completion Date

December 1, 2016

Last Updated

April 18, 2018

Enrollment

ACTUAL participants

Conditions

DyschromiaPhotodamaged Skin

Interventions

HALO

DEVICE

2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles

NCT07222397

Photodamaged SkinRhytids+2 more

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TERMINATEDPHASE4

Duration of Ameluz Application in Acral Actinic Keratoses Response

NCT03963102

Actinic KeratosesPhotodamaged Skin

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy Study for Various Skin Conditions

Inclusion Criteria

Exclusion Criteria

2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles

Duration of Ameluz Application in Acral Actinic Keratoses Response

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