Post-market Cosmetic Evaluation of Ariessence™ Pure PDGF+ Following Ablative Laser

Lynch Regenerative Medicine21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Immediate Post-Treatment Care Aging Mid-Face Aging

Interventions

ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF).OTHER

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (2)

Laser & Skin Surgery Medical Group

Sacramento, California, United States

RECRUITING

The Practice of Brian S. Biesman, MD

Nashville, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

Clinical Measures

Glogau Scale

Time frame: Baseline (Day 0) through Day 84 (End of Study).

Patient-Reported Outcomes

FACE-Q, SKIN-Q, FACE-Q Psychological Function, treatment Discomfort/Pain Evaluation Subject Satisfaction Scale

Time frame: Baseline through day 84

Photography

VISIA-CR (standardized frontal ±45°), FitSkin (regional close-ups), and point-and-shoot baseline and follow-ups

Time frame: Baseline through Day 84

Investigator Objective Tolerability Assessment

Tolerability of product

Time frame: Baseline through Day 84

Erythema grading (0-4 scale)

Degree of erthema

Time frame: Baseline through Day 84 (End of Study)

Clinician's Global Aesthetic Improvement Scale (CGAIS).

Measure of Aestetic Imporvement

Time frame: Baseline through Day 84 (End of STudy)