Aging, Aging Mid-Face, Immediate Post-Treatment Care
Conditions
Keywords
PDGF, aging skin, post-laser treatment, ariessence
Brief 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.
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.
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
Sponsors
Lynch Regenerative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Measures | Baseline (Day 0) through Day 84 (End of Study). | Glogau Scale |
| Patient-Reported Outcomes | Baseline through day 84 | FACE-Q, SKIN-Q, FACE-Q Psychological Function, treatment Discomfort/Pain Evaluation Subject Satisfaction Scale |
| Photography | Baseline through Day 84 | VISIA-CR (standardized frontal ±45°), FitSkin (regional close-ups), and point-and-shoot baseline and follow-ups |
| Investigator Objective Tolerability Assessment | Baseline through Day 84 | Tolerability of product |
| Erythema grading (0-4 scale) | Baseline through Day 84 (End of Study) | Degree of erthema |
| Clinician's Global Aesthetic Improvement Scale (CGAIS). | Baseline through Day 84 (End of STudy) | Measure of Aestetic Imporvement |
Countries
United States
Contacts
CONTACTJosh Arnold
Outcome results
None listed