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

Skin Flaccidity Inner Thighs Knees Arms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113265
• Other study ID #: E0719
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: Derming SRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Flaccidity Inner Thighs Knees Arms

Intervention

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)

Locations

Country	Name	City	State
Italy	DERMING	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Derming SRL

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Primary	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)	baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Primary	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)	baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Primary	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)	baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Primary	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)	baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Primary	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)	baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Primary	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.	baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Primary	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)	baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Primary	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.	baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Primary	Change from baseline of photographic documentation	2D pictures of the inner arm, thigh and knee	baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks