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Completed

NCT Number: NCT04113265

Aesthetic Performance of an Injective 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.

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Key information

Conditions

Skin Flaccidity Inner Thighs Knees Arms

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DERMING

Milan, MI, 20159, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SUNEKOS ® Body

Device

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)

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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.

  8. 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)

  9. 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.

  10. 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

Sponsors and collaborators

Lead sponsor

Derming SRL

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2019
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.