Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-70
SponsorSkincare Physicians of Chestnut Hill

About this trial

The first goal of this clinical trial is to learn if topical application of PLLA in conjunction with a microneedling treatment works to treat perioral wrinkles in adults. The second goal is to see whether the application of topical PLLA is more effective before or after a microneedling treatment. The main questions it aims to answer are:

* Is PLLA present within the MN channels from in vivo biopsy samples? * Is it safe to combine topical PLLA and MN in the treatment of perioral wrinkles, as determined by the incidence and severity of adverse events in healthy subjects? * Does overall aesthetic and skin texture improve in combining microneedling with topical PLLA in the treatment of mild to moderate perioral wrinkles? * Is it the treatment of topical PLLA more effective when applied before or after a microneedling treatment.

Researchers will compare the application of PLLA before a microneedling treatment to a microneedling treatment with PLLA application after to see which treatment method is more effective.

Participants will:

\- receive 2 treatments spaced 4-6 weeks apart of topical PLLA and microneedling

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Poly-L-Lactic Acid
  • Microneedling

Treatment groups

26 Participants
are divided into 2 treatment groups

Sponsors and collaborators