A Multi-center, Post-market Cosmetic Evaluation of Ariessence™ Pure PDGF+ Following Ablative Laser for the Tolerability and Improvement in the Appearance of Aging Skin.
Lynch Regenerative Medicine
Summary
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.
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.
Eligibility
- Age range
- 40–70 years
- Sex
- All
- 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.
Interventions
- Otherariessence 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
Locations (2)
- Laser & Skin Surgery Medical GroupSacramento, California
- The Practice of Brian S. Biesman, MDNashville, Tennessee