Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06451822
Study type Interventional
Source Mesoestetic Pharma Group S.L.
Contact
Status Completed
Phase N/A
Start date February 3, 2022
Completion date July 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT04276753 - A Randomized, Double-blinded, Placebo Controlled, Monocentric Study to Evaluate the Anti-ageing and Skin Brightening Benefit of the Test Product in Healthy Female Subjects N/A
Completed NCT06125912 - A Comparative Split-Face Study of the Effects of a Retinol Alternative Cream on Improving Facial Skin Aging N/A
Completed NCT02580370 - Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines Phase 3
Recruiting NCT01583478 - Comparison of Escalating Doses of IncobotulinumtoxinA (Xeomin®) in the Treatment of Glabellar Rhytids Phase 4
Completed NCT02003833 - Poly-L-lactic Acid for Skin Quality Phase 4
Completed NCT01447342 - A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines Phase 2/Phase 3
Completed NCT00974480 - Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging N/A
Completed NCT00986570 - Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face Phase 3
Completed NCT00272610 - Topical Vitamin A Versus Vehicle Cream in the Treatment of Aged Skin Phase 2
Recruiting NCT03730649 - Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure Early Phase 1
Completed NCT03312543 - Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles N/A
Active, not recruiting NCT05349799 - TEOSYAL RHA® 1 for Neck Lines, Perioral Lines and Smiling Lines N/A
Completed NCT03677258 - Effectiveness and Safety of Collagen Complex COLLOST in Anti-age Therapy N/A
Withdrawn NCT05854628 - The Role of Red Flavonoid in Photoaging N/A
Completed NCT01981980 - Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation N/A
Not yet recruiting NCT00767156 - Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging N/A
Recruiting NCT05813054 - Clinical Study to Evaluate the Anti-aging Efficacy of Dermial® N/A
Completed NCT05457491 - Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE) Phase 1
Not yet recruiting NCT04485091 - TCA Peel and Photobiomodulation for Hand Rejuvenation Phase 2
Completed NCT01237977 - Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines Phase 3