NCT06451822

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

An Open-label Uncontrolled Single Centre Investigation for the Evaluation of the Safety and Performance Characteristics of the Dermal Filler mIntense L+AS, Hyaluronic Acid 25 mg/ml (M-INT-LS) for Soft Tissue Augmentation to Correction of Moderate to Deep Wrinkles and Folds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Mesoestetic Pharma Group S.L. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

The product mIntense L+AS is a dermal filler manufactured by mesoestetic Pharma Group s.l. It was intended to be used as a temporary filler to correct small skin defects, such as wrinkles or scars. In particular, it was recommended for the treatment of deep wrinkles. mIntense L+AS for the facial area is a sterile, injectable, gel colourless, transparent, non-pyrogenic, reabsorbable product containing cross-linked hyaluronic acid of non-animal origin, produced via bacterial fermentation. This clinical investigation was conducted as an uncontrolled - no comparator was used. The safety and performance of the treatment were evaluated by comparison of the condition with the state of the treated area before initiation of the procedure, conducted by the trained Principal Investigator. The investigated product mIntense L+AS was applied by intradermal or subcutaneous injection by the investigator during Session 1 for all subjects and Session 2 for the subjects, for whom a touch-up was considered beneficial. Both sessions were conducted within 14-day intervals. The evaluation process during the medical examination was facilitated by photographic evidence taken before and after therapy at predetermined time points for reference.

Conditions

• Skin Aging
• Skin Wrinkling

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-03
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2024-06-11
• Last updated: 2024-06-11

Locations

1 site across 1 country: Bulgaria