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Comparison of Safety and Efficacy of New Metallic Cannula Versus Standard Needle to Inject Hyaluonic Acid for Nasolabial Fold

2014-08-27 03:16:01 | BioPortfolio

Summary

The purpose of this study was to assess the safety and efficacy of a new metallic cannula to inject Hyaluonic acid for dermal augmentation in the nasolabial foldscomparde to standard needle.

Description

This was a monocentric, prospective, randomized, phase II and double-blind study.

At the baseline visits, one investigator rated the severity of nasolabial folds on both left and right sides according to the mentioned scale, and a standard set of six photographs of the face (frontal, left side and right side for both the whole face and the lower face) were taken.

On the day of the injection, the main investigator injected 1ml of dermal filler - hyaluronic acid (Restylane®, Q-Med, Uppsala, Sweden) - for each subject. The injected amount was 0,5ml for the right nasolabial fold and 0,5ml for the left nasolabial fold. The choosen side willbe randomized.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Nasogenian Fold

Intervention

Injection of hyaluronic acid in nasogenian folds

Location

Brazilian Center for Studies in Dermatology
Porto Alegre
Rio Grande do Sul
Brazil
90570-040

Status

Recruiting

Source

Brazilan Center for Studies in Dermatology

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:01-0400

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Medical and Biotech [MESH] Definitions

A group of high molecular weight chondroitin sulfate proteoglycans that form aggregates with HYALURONIC ACID.

Materials such as COLLAGEN or HYALURONIC ACID that are injected or deposited into the DERMIS for the purpose of skin augmentation.

The two longitudinal ridges along the PRIMITIVE STREAK appearing near the end of GASTRULATION during development of nervous system (NEURULATION). The ridges are formed by folding of NEURAL PLATE. Between the ridges is a neural groove which deepens as the fold become elevated. When the folds meet at midline, the groove becomes a closed tube, the NEURAL TUBE.

An inflammatory reaction involving the folds of the skin surrounding the fingernail. It is characterized by acute or chronic purulent, tender, and painful swellings of the tissues around the nail, caused by an abscess of the nail fold. The pathogenic yeast causing paronychia is most frequently Candida albicans. Saprophytic fungi may also be involved. The causative bacteria are usually Staphylococcus, Pseudomonas aeruginosa, or Streptococcus. (Andrews' Diseases of the Skin, 8th ed, p271)

Mucoid states characterized by the elevated deposition and accumulation of mucin (mucopolysaccharides) in dermal tissue. The fibroblasts are responsible for the production of acid mucopolysaccharides (GLYCOSAMINOGLYCANS) in the ground substance of the connective tissue system. When fibroblasts produce abnormally large quantities of mucopolysaccharides as hyaluronic acid, chondroitin sulfate, or heparin, they accumulate in large amounts in the dermis.

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