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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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)
DERMING
Milan, MI, Italy
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks