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Purpose

ariessence is intended to be used as a viscous, leave-on solution designed for topical application to the face. It is intended to be used following non-medical cosmetic procedures, performed by licensed healthcare professionals to enhance comfort and maintain skin hydration. This study is designed to be a multi-center, post-market cosmetic evaluation of ariessence applied to the full face after an ablative laser procedure to evaluate improvements in procedure tolerability and improvements in the appearance of the skin, compared to an emollient control.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • :Adults 40-65 70 years - Glogau III-IV - Fitzpatrick II-IV. - Suitable for ablative laser - non-smoker ≥ 3 years - Willing to comply with post-procedure regimen - patient reported outcome documentation, and photo documentation.

Exclusion Criteria

  • Fitzpatrick I or > IV, - recent facial procedures (< 6 months) - active skin disease - pregnancy/lactation - implanted devices - history of keloids.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Prospective, randomized (2:1), evaluator blind placebo-controlled trial. All participants will receive UltraClear Laser Treatment. Intervention is a post-market evaluation following non-investigational elective laser treatment of the face as prescribed in the device label
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
ariessence pure PDGF+ 		ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF).
  • Other: ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF).
    To compare time to appearance-based recovery and subject satisfaction between ariessence and standard of care groups using standardized photographs and investigator/subject ratings for tolerability and satisfaction
Placebo Comparator
standard of care 		The non-treatment control group will be treated only with the SOC (Aquaphor or equivalent emoilment) and post-procedure instructions.
  • Other: ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF).
    To compare time to appearance-based recovery and subject satisfaction between ariessence and standard of care groups using standardized photographs and investigator/subject ratings for tolerability and satisfaction

Recruiting Locations

Laser & Skin Surgery Medical Group
Sacramento, California 95816
Contact:
Suzanne Kilmer, MD
916-456-0400
Nathan.Smith@purity-health.com

The Practice of Brian S. Biesman, MD
Nashville, Tennessee 37203
Contact:
Brian S Biesman, MD
615-329-1110
Nathan.Smith@purity-health.com

More Details

Status
Recruiting
Sponsor
Lynch Regenerative Medicine

Study Contact

Josh Arnold
302-604-4532
clinicaltrials@purity-health.com

Detailed Description

To compare procedure tolerability of the treated facial area between ariessence and standard aftercare (Aquaphor). Tolerability, using subject tolerability assessments (subject diaries), investigator tolerability assessments, and standardized day-3/7/14 photographs, with site confirmation.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.