Skin Flaccidity Inner Thighs Knees ArmsNCT04113265
Aesthetic Performance of an Injective Treatment for the Inner Thighs, Knees and Arms
A study testing SUNEKOS ® Body in people with Skin Flaccidity Inner Thighs Knees Arms, run by Derming SRL at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Flaccidity Inner Thighs Knees Arms
- What is being tested?
- SUNEKOS ® Body
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Skin Flaccidity Inner Thighs Knees Arms
- Being tested
- SUNEKOS ® Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUNEKOS ® BodyDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| SUNEKOS ® Body | Experimental | 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). Receives: Device: SUNEKOS ® Body |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of inner arm skin laxity clinical grade
Skin laxity clinical grade, according to a visual score from 1 (no flaccidity) to 5 (very severe flaccidity)
Measured: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner arm skin roughness clinical grade
Skin roughness clinical grade, according to a visual score from 1 (no roughness) to 5 (very severe roughness)
Measured: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner thigh skin laxity clinical grade
Skin laxity clinical grade, according to a visual score from 1 (no flaccidity) to 5 (very severe flaccidity)
Measured: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner thigh skin roughness clinical grade
Skin laxity clinical grade, according to a clinical score from 1 (no roughness) to 5 (very severe roughness)
Measured: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner knee skin laxity clinical grade
Skin laxity clinical grade, according to a clinical score from 1 (no flaccidity) to 5 (very severe flaccidity)
Measured: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner knee skin roughness clinical grade
Skin laxity clinical grade, according to a visual score from 1 (no roughness) to 5 (very severe roughness)
Measured: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of superficial skin hydration
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.
Measured: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of deep skin hydration
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)
Measured: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of skin density
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.
Measured: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of photographic documentation
2D pictures of the inner arm, thigh and knee
Measured: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start20 May 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Flaccidity Inner Thighs Knees ArmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adele Sparavigna, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113265
- Sponsor's protocol ID
- E0719
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Performance and Tolerance Evaluation of an Injective Intradermal Treatment for the Inner Thighs, Knees and Arms
- ClinicalTrials.gov ID
- NCT04113265
- Acronym / sponsor ID
- E0719
- Conditions
- Skin Flaccidity Inner Thighs Knees Arms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUNEKOS ® Body | Experimental | Device: SUNEKOS ® BodyThe 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). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUNEKOS ® BodySUNEKOS ® 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) | Device | SUNEKOS ® Body |
Primary outcome
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)
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)
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)
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)
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)
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)
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.
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)
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUNEKOS ® Body in people with Skin Flaccidity Inner Thighs Knees Arms, run by Derming SRL at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.