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

NCT07718347 | Recruiting DMC

• 1 other identifier: LRM-ARS-PLF 401
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Aging; Immediate Post-Treatment Care; Aging Mid-Face

Keywords

PDGF; aging skin; post-laser treatment; ariessence

Outcome Measures

Primary Outcomes (6)

• Clinical Measures

  Glogau Scale

  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

  Baseline through day 84

• Photography

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

  Baseline through Day 84

• Investigator Objective Tolerability Assessment

  Tolerability of product

  Baseline through Day 84

• Erythema grading (0-4 scale)

  Degree of erthema

  Baseline through Day 84 (End of Study)

• Clinician's Global Aesthetic Improvement Scale (CGAIS).

  Measure of Aestetic Imporvement

  Baseline through Day 84 (End of STudy)

Study Arms (2)

ariessence pure PDGF+

ACTIVE COMPARATOR

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).

standard of care

PLACEBO COMPARATOR

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).

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

ariessence pure PDGF+; standard of care

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• :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.

You may not qualify if:

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

Sponsors & Collaborators

• Lynch Regenerative Medicine: lead

Study Sites (2)

Laser & Skin Surgery Medical Group

Sacramento, California, 95816, United States

RECRUITING

The Practice of Brian S. Biesman, MD

Nashville, Tennessee, 37203, United States

RECRUITING

Related Publications (2)

• Sharma AN, Patel BC. Laser Fitzpatrick Skin Type Recommendations. In: StatPearls. StatPearls Publishing; 2025. Accessed October 28, 2025. http://www.ncbi.nlm.nih.gov/books/NBK557626/

  BACKGROUND

• Glogau RG. Aesthetic and anatomic analysis of the aging skin. Semin Cutan Med Surg. 1996 Sep;15(3):134-8. doi: 10.1016/s1085-5629(96)80003-4.

  PMID: 8948530 BACKGROUND

MeSH Terms

Interventions

Platelet-Derived Growth Factor

Intervention Hierarchy (Ancestors)

Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Blood Proteins; Proteins; Biological Factors

Central Study Contacts

Josh Arnold

CONTACT

302-604-4532; clinicaltrials@purity-health.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: July 21, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: within 12 months of study completion
• Access Criteria: Avaialble upon reasonable request to sponsor

Locations

US (2)