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PLLA and CaHA-R for Aesthetic Rejuvenation

NCT07202117 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-10-01

No results posted yet for this study

Summary

Skin ageing is intricately linked to collagen degradation caused by internal and external factors. External factors contributing to ageing include ultraviolet rays, smoking, heat, and air pollution, and follow a distribution across the body according to the level of exposure. Whereas internal ageing occurs as a natural consequence of physiological changes over time. As we age, both natural internal and external factors cause stress to the body. This stress damages important molecules in our skin, including proteins, fats (lipids), and DNA. One of the main proteins affected is collagen, which gives skin its strength and firmness. This loss of collagen leads to visible signs of aging such as wrinkles, thinner skin (atrophy), rough or damaged texture (elastosis), and uneven skin tone (dyschromia).

Interventions such as collagen stimulators have shown promising outcomes in stimulating cells to produce collagen, thereby improving skin elasticity and firmness. Poly-L-Lactic Acid is a biodegradable long-chain polymer of repeating units of lactic acid derived from alpha-hydroxy acid. Injecting PLLA into the deep dermis or subcutaneous tissue, stimulates collagen production through an inflammatory response, resulting in skin rejuvenation that can last between two to three years. In contrast, CaHA-R drives the regeneration of collagens, elastin, and proteoglycans with minimal immune cell recruitment and immediate volume improvement lasting around 12-18 months. To date, there have been no randomized-controlled-trials comparing the efficacy of PLLA vs CaHa-R for skin rejuvenation in the face and body.

Conditions

  • Aesthetic

Interventions

DEVICE

Sculptra Aesthetic

Sculptra® Aesthetic is manufactured by Galderma Laboratories. It is a sterile, lyophilized preparation of PLLA that is biocompatible and biodegradable. Each vial contains 367.5 mg of freeze-dried powder, including 150 mg of PLLA. Prior to injection, it will be reconstituted with sterile water for injection (SWFI) and lidocaine hydrochloride (2%). For this study, commercial products will be used. The study products are for single use only.

DEVICE

Radiesse

Radiesse® is manufactured by Merz Aesthetics. It is a sterile, non-pyrogenic, semi-solid injectable implant composed of synthetic CaHA suspended in a gel carrier of sterile water, glycerin, and sodium carboxymethylcellulose. Each pre-filled syringe contains 1.5 mL of product. The product includes 0.3% lidocaine for pain reduction during injection. For this study, commercial products will be used. The study products are for single use only.

Sponsors & Collaborators

  • Erevna Innovations Inc.

    lead OTHER

Principal Investigators

  • Andreas Nikolis, MD, PhD · Erevna Innovations Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-11-01
Completion
2026-12-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07202117 on ClinicalTrials.gov