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)

NCT ID: NCT03425955

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-19
• Study Completion Date: 2017-12-21

Brief 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).

Detailed Description

Spontaneous, open, clinical trial, conducted by one centre under dermatological control. Primary end point of the study was to evaluate clinically and by non-invasive instrumental measurements the 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.

The micro-injections of the study product were executed by a specialized dermatologist, on the face of female volunteers with photoaging of mild/moderate grade; to improve the treatment aesthetic performance two different injection techniques were carried out mono-laterally on the left or right face side randomly: "interstitial fluid technique" (IFT) for the 1st subjects' typology (aged 35-50 years) and "cushion technique" in association to "retrograde interstitial fluid technique" (RIFT) for the 2nd (aged 45-60). On the contralateral face side the injection treatment was performed by bolus technique on five pre-determined face points, preceding for the 2nd subjects' typology by cushion technique.

It was also aim of this study to evaluate tolerance both by investigator and volunteers and efficacy by the volunteers

Conditions

Face Photoaging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GROUP 1

Normotypic or overweight subjects with rounded, oval or squared face (aged 35-50 years)

Group Type: EXPERIMENTAL

SUNEKOS ® 200

Intervention Type: DEVICE

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.

GROUP 2

Thin subjects with oval or triangular face and "sagging" skin (aged 45-60 years)

Group Type: EXPERIMENTAL

"SUNEKOS® 1200" and "SUNEKOS® 200"

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• female sex,
• age 35-50 years for the group 1 and 45-60 years for the group 2,
• mild/moderate cutaneous photoaging according to a reference photographic scale
• skin phototype I, II and III according to Fitzpatrick's classification, with a preference to grade II-III ,
• agreeing to present at each study visit without make-up,
• accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products,
• accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study,
• accepting to sign the informed consent form.

Exclusion Criteria

• Pregnancy,
• lactation,
• subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study,
• subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, 30 days (T4i) and 60 days (T60) after the first injection procedure,
• Body Mass Index (BMI) variation (± 1) during the study period,
• performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 12 months prior to the study start;
• performing permanent filler in the past,
• change in the normal habits regarding food, physical activity, face cosmetic, cleansing and make-up use during the month preceding the test,
• sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit),
• subjects whose insufficient adhesion to the study protocol is foreseeable,
• presence of cutaneous disease on the tested area, as lesions, scars, malformations,
• recurrent facial/labial herpes,
• clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
• diabetes,
• endocrine disease,
• hepatic disorder,
• renal disorder,
• cardiac disorder,
• pulmonary disease,
• cancer,
• neurological or psychological disease,
• inflammatory/immunosuppressive disease,
• drug allergy,
• anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
• using of drugs able to influence the test results in the investigator opinion. The use of other drugs, not mentioned above, can be authorized by the Investigator.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Derming SRL

OTHER

Sponsor Role: lead

Responsible Party

Adele Sparavigna

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

DERMING

Milan, MI, Italy

Countries

Italy

Other Identifiers

E1817

Identifier Type: -

Identifier Source: org_study_id