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Efficacy and Performance Evaluation of mIntense L+AS 25 mg/ml Hyaluronic Acid for the Correction of Moderate to Deep Wrinkles and Folds

NCT06451822 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-06-11

No results posted yet for this study

Summary

The investigation is a single-centre, interventional, prospective, non-randomized, open-label, uncontrolled, single-arm, un-blinded investigation for evaluation of the safety and performance of the product mIntense L+AS in the treatment of small skin defects, such as wrinkles or scars. The clinical investigation is interventional and prospective in agreement with the pre-market regulatory status of the product.

Conditions

  • Skin Aging
  • Skin Wrinkling

Interventions

DEVICE

mIntense L+AS

The investigated dermal filler mIntense L+AS is intended to be used as a temporary filler, administered by intradermal or subcutaneous injections, to correct small skin defects, such as wrinkles or scars.

Sponsors & Collaborators

  • Mesoestetic Pharma Group S.L.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Bulgaria

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 NCT06451822 on ClinicalTrials.gov