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Aesthetic Performance of an Intradermal Injection Treatment for Face Photoaging: Interstitial or Cushion Technique in Comparison to Bolus Technique at Five Points (Half - Face Method Within Subjects)

NCT03425955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-02-08

No results posted yet for this study

Summary

Aesthetic performance of "SUNEKOS® 200" injectable treatment on main sign of face skin aging in normotypic or overweight subjects with rounded, oval or squared face and in thin subjects with oval or triangular face and "sagging" skin.Interstitial or cushion technique in comparison to bolus technique at five points (half - face method within subjects).

Conditions

  • Face Photoaging

Interventions

DEVICE

SUNEKOS ® 200

4 micro-injection sessions of "SUNEKOS® 200" with an interval of 10 days. Two different injection techniques were carried out mono-laterally on the left or right face side randomly: "interstitial fluid technique" (IFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side.

DEVICE

"SUNEKOS® 1200" and "SUNEKOS® 200"

5 micro-injection sessions (one of the product "SUNEKOS® 1200" and four of "SUNEKOS® 200". "SUNEKOS® 1200" was injected bi-laterally on the face with cushion technique. 24 hours after the "SUNEKOS® 1200" treatment, 4 micro-injection sessions of "SUNEKOS® 200" with an interval of 10 days were performed . "SUNEKOS® 200" was injected with two different techniques, carried out mono-laterally on the left or right face side randomly: "retrograde interstitial fluid technique" (RIFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side.

Sponsors & Collaborators

  • Derming SRL

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2017-12-21
Completion
2017-12-21

Countries

  • Italy

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 NCT03425955 on ClinicalTrials.gov