Aesthetic Performance of an Injective Treatment for the Inner Thighs, Knees and Arms

October 2, 2019 updated by: Adele Sparavigna, Derming SRL

Aesthetic Performance and Tolerance Evaluation of an Injective Intradermal Treatment for the Inner Thighs, Knees and Arms

The objective of this study is to investigate the efficacy of the "SUNEKOS® Body" in woman aged 40-65 years with skin flaccidity of the inner thighs, knees and arms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20159
        • DERMING

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female sex;
  • age 40-65 years;
  • asking for inner thighs, knees and arms laxity restoration;
  • available and able to return to the study site for the post-procedural follow-up examinations;
  • accepting to not change their habits regarding food, physical activity, cosmetic and cleansing products for the body;
  • accepting not to expose their body to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;
  • accepting to sign the informed consent form.

Exclusion Criteria:

  • Pregnancy;
  • lactation;
  • smokers;
  • alcohol abuse and/or drug use;
  • 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 at T0 (before the 1st aesthetic procedure) and at T4i (before the last injection treatment execution);
  • Body Mass Index (BMI) variation (± 1) during the study period;
  • performing skin treatments for knee, thighs and arms aesthetic correction (carboxytherapy injections, body lifting, laser, infrared light, bipolar radiofrequency, vacuum and mechanical massage) in the 6 months prior to the study start;
  • aesthetic surgical procedure on knee, thighs and arms in the past;
  • change in the normal habits regarding food, physical activity, cosmetic products and cleansing for the body 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;
  • participation in a similar study currently or during the previous 6 months
  • Dermatitis;
  • 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, psoriasis, severe rosacea, scleroderma, local infections and severe acne).
  • Diabetes;
  • endocrine disease;
  • hepatic disorder;
  • renal disorder;
  • cardiac disorder;
  • pulmonary disease;
  • cancer;
  • neurological or psychological disease;
  • inflammatory/immunosuppressive disease;
  • drug allergy.
  • Anticoagulants and antiplatelet 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SUNEKOS ® Body
The 1st treatment was performed during T0 visit, after the basal evaluations planned by the study procedure and repeated 3 more times with an interval of 1 week (T2i, T3i and T4i).
Device: SUNEKOS ® Body
SUNEKOS ® Body is a medical device (class III). The study product was injected at level of the inner thighs, knees and arms by needle (29 G) using the interstitial fluid technique (IFT)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline of inner arm skin laxity clinical grade
Time Frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin laxity clinical grade, according to a visual score from 1 (no flaccidity) to 5 (very severe flaccidity)
baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner arm skin roughness clinical grade
Time Frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin roughness clinical grade, according to a visual score from 1 (no roughness) to 5 (very severe roughness)
baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner thigh skin laxity clinical grade
Time Frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin laxity clinical grade, according to a visual score from 1 (no flaccidity) to 5 (very severe flaccidity)
baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner thigh skin roughness clinical grade
Time Frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin laxity clinical grade, according to a clinical score from 1 (no roughness) to 5 (very severe roughness)
baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner knee skin laxity clinical grade
Time Frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin laxity clinical grade, according to a clinical score from 1 (no flaccidity) to 5 (very severe flaccidity)
baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner knee skin roughness clinical grade
Time Frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin laxity clinical grade, according to a visual score from 1 (no roughness) to 5 (very severe roughness)
baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of superficial skin hydration
Time Frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Skin electrical capacitance value was measured mono-laterally on the right or left inner arm, thigh and knee with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.
baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of deep skin hydration
Time Frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the right or left inner arm, thigh and knee with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of skin density
Time Frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
A little skin area of about 7 cm2 (at level of inner arm was pinched, in standardized conditions, using a specific device. Because of this "pinch" the skin profile changes depending on cutaneous density; when the skin is slack the "pinch" forms a lot of wrinkles. A picture of the skin pinched was taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters.
baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of photographic documentation
Time Frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
2D pictures of the inner arm, thigh and knee
baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Derming SRL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E0719

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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