Immediate Post-Treatment CareNCT07718347
Post-market Cosmetic Evaluation of Ariessence™ Pure PDGF+ Following Ablative Laser
A study testing ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF). in people with Immediate Post-Treatment Care and Aging Mid-Face, run by Lynch Regenerative Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Immediate Post-Treatment Care, Aging Mid-Face, Aging
- What is being tested?
- ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF).
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Apr 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -: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.
Who cannot join
- Fitzpatrick I or > IV,
- recent facial procedures (< 6 months)
- active skin disease
- pregnancy/lactation
- implanted devices
- history of keloids.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Practice of Brian S. Biesman, MD
Nashville, Tennessee, 37203
Brian S Biesman, MD, 615-329-1110, Nathan.Smith@purity-health.com
- Recruiting
Laser & Skin Surgery Medical Group
Sacramento, California, 95816
Suzanne Kilmer, MD, 916-456-0400 ext. 216, Nathan.Smith@purity-health.com
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Immediate Post-Treatment Care, Aging Mid-Face, Aging
- Being tested
- ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF).
- Keywords
- PDGF, aging skin, post-laser treatment, ariessence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| ariessence pure PDGF+ | Active comparator | ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF). Receives: 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. Receives: Other: ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Measures
Glogau Scale
Measured: 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
Measured: Baseline through day 84
Photography
VISIA-CR (standardized frontal ±45°), FitSkin (regional close-ups), and point-and-shoot baseline and follow-ups
Measured: Baseline through Day 84
Investigator Objective Tolerability Assessment
Tolerability of product
Measured: Baseline through Day 84
Erythema grading (0-4 scale)
Degree of erthema
Measured: Baseline through Day 84 (End of Study)
Clinician's Global Aesthetic Improvement Scale (CGAIS).
Measure of Aestetic Imporvement
Measured: Baseline through Day 84 (End of STudy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start16 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immediate Post-Treatment CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lynch Regenerative Medicine
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718347
- Sponsor's protocol ID
- LRM-ARS-PLF 401
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data available upon reasonable request
Publications
Sharma AN, Patel BC. Laser Fitzpatrick Skin Type Recommendations. 2023 Mar 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557626/
PubMed 32491558Glogau 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.
PubMed 8948530
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07718347
- Acronym / sponsor ID
- LRM-ARS-PLF 401
- Conditions
- Immediate Post-Treatment Care, Aging Mid-Face, Aging
- Keywords
- PDGF, aging skin, post-laser treatment, ariessence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Lynch Regenerative MedicineResearch network
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ariessence pure PDGF+ | Active comparator | Other: ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF).ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF). |
| standard of care | Placebo comparator | Other: ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF).The non-treatment control group will be treated only with the SOC (Aquaphor or equivalent emoilment) and post-procedure instructions. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- -:Adults 40-65 70 years
- Glogau III-IV
- Fitzpatrick II-IV.
- Suitable for ablative laser
- non-smoker ≥ 3 years
Key exclusion criteria (6 listed)
- Fitzpatrick I or > IV,
- recent facial procedures (< 6 months)
- active skin disease
- pregnancy/lactation
- implanted devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | ariessence pure PDGF+, standard of care |
Primary outcome
Clinical Measures
Time frame: Baseline (Day 0) through Day 84 (End of Study).
Glogau Scale
Patient-Reported Outcomes
Time frame: Baseline through day 84
FACE-Q, SKIN-Q, FACE-Q Psychological Function, treatment Discomfort/Pain Evaluation Subject Satisfaction Scale
Photography
Time frame: 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
Time frame: Baseline through Day 84
Tolerability of product
Erythema grading (0-4 scale)
Time frame: Baseline through Day 84 (End of Study)
Degree of erthema
Clinician's Global Aesthetic Improvement Scale (CGAIS).
Time frame: Baseline through Day 84 (End of STudy)
Measure of Aestetic Imporvement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 32491558Sharma AN, Patel BC. Laser Fitzpatrick Skin Type Recommendations. 2023 Mar 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557626/
- Background: PubMed 8948530Glogau 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.
- Individual participant dataSharing planned: Yes. Deidentified data available upon reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ariessence pure PDGF+™ is a sterile aqueous formulation containing Hyaluronic Acid and pure platelet-derived growth factor (PDGF). in people with Immediate Post-Treatment Care and Aging Mid-Face, run by Lynch Regenerative Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josh Arnold (302-604-4532, clinicaltrials@purity-health.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Measures (time frame: Baseline (Day 0) through Day 84 (End of Study).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07718347, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.