Can a cream and tiny needles erase lip lines? new study aims to find out
NCT ID NCT07225348
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether applying a cream called poly-L-lactic acid (PLLA) during microneedling can reduce wrinkles around the mouth in adults aged 40 to 70. Participants will receive two treatments, and researchers will compare applying the cream before versus after microneedling to see which works better. The goal is to improve skin texture and appearance safely.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2025
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males and non-pregnant, non-lactating females 40-70 years of age * Fitzpatrick Skin Type I-IV * Wrinkle severity graded by the investigator (1-3 on Lemperle scale) * Able to provide written informed consent, understand and be willing to comply with all study related procedures and follow-up visits * Signed informed consent obtained before any study-specific procedure is performed. Exclusion Criteria: * Lesions suspicious for any malignancy, actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the area to be treated * Tenderness in the treatment rea * History of keloid formation or hypertrophic scarring * History of trauma or surgery to the treatment area * Scar present in the areas to be treated * Silicone or synthetic material injections in the areas to be treated * Injection of fat, collagen, hyaluronic acid or other dermal fillers in the areas to be treated within the previous 12 months * History of treatment with dermabrasion or laser in the areas to be treated within the previous 12 months * History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months * Active smokers (0.5 pack/day) or having quit within 3 months prior treatment * Active, chronic, or recurrent infection * History of compromised immune system or currently being treated with immunosuppressive agents * History of sensitivity to analgesic agents, Aquaphor, topical or local anesthetics * Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment * Treatment with fish oil within 14 days prior to treatment * Treatment with aspirin or other blood thinning agents within 14 days prior to treatment * History or presence of any clinically significant bleeding disorder * Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements * History of drug and/or alcohol abuse * Any issue that, at the discretion of the investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to safely undergo study procedures or give informed consent * Treatment with an investigational device or agent within 30 days before treatment or during the study period
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Perioral wrinkles are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
SkinCare Physicians
RECRUITINGChestnut Hill, Massachusetts, 02467, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.