IITP  /  Clinical data & research

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Clinical data & research

The IITP scientific archive — clinical studies on MIG3® far infrared, conducted with universities and research centers in Brazil.

20 studies USP · UNIFESP · UNICAMP · Univap Journal of Drugs in Dermatology

Every study is a scientific congress banner. Summaries are in English and Portuguese; the full banner opens in English.

01

Microcirculation & nitric oxide

ANVISA/MS 80104760007

Fabric with MIG3® Bioceramics and production of the gasotransmitter nitric oxide (NO)

UNIFESP — Neuromuscular Diseases; Statpharm; Invel; Probiotec

Salivary nitric oxide was significantly higher with MIG3® fabric than with control (71.65 vs 47.76; p = 0.0067), supporting blood flow, peripheral vasodilation and local microcirculation.

Design: Open-label, randomized, cross-over — two treatments, two 7-day periods Sample: 30 healthy men, 21–40 years Schmidt B, Mesquita e Silva T, Wada CY, Simões RP, Nishimura CM, Pupo STM, Espíndola FS
02

Pain & musculoskeletal

ANVISA/MS 80104760006

Invel® Actiive Glove — efficacy and safety in myofascial wrist pain

Pain Group, Hospital das Clínicas — School of Medicine, USP; Statpharm; Invel

About 55% reduction in wrist pain (VAS) and improved DASH function (p < 0.0001), with no significant adverse events.

Design: Single-center, prospective, double-blind, randomized, placebo-controlled Sample: 60 subjects with myofascial pain (RSI), 28 days Kaziyama HHS, Teixeira MJ, Oliveira RB, Nishimura CM, Kaziyama VM, Targino RA, Leão Ferreira KAS, Wada CY, Simões RP
ANVISA/MS 80104760005

Invel® Actiive Shirt — efficacy and safety in chronic low back pain

Pain Group, Hospital das Clínicas — USP; Statpharm; Invel; InfraRedMed

44% reduction in back pain; significant global improvement vs placebo (p = 0.0362) and 24% vs 11% improvement in thermographic perfusion.

Design: Single-center, randomized, double-blind, placebo-controlled Sample: 70 subjects with chronic low back pain Teixeira MJ, Araújo JO, Kaziyama HHS, Andrade DC, Nishimura CM, Lima MLA, Wada CY, Simões RP, Pupo STM, Brioschi ML

Bioceramic fabric applied to painful areas of the spinal column

UNICAMP/HC — Physiotherapy, Spinal Clinic

Pain relief in all patients and complete disappearance of pain in 3 of 22.

Design: Prospective, VAS + categorical pain scale, 4 weeks Sample: 22 patients with spinal pain Machado DP, Rodrigues A

Bioceramic fabric on spinal column pain (neuromuscular)

UNIFESP-EPM — Neurology & Neurosurgery, Neuromuscular Diseases

Pain relief in all patients and disappearance of pain in 2 of 15, with no gender or age differences.

Design: Prospective, descriptive, VAS, 30 days Sample: 15 patients with chronic pain Ramos PE, Abe GC, Oliveira ASB

Invel® Dome infrared chamber for neuropathic pain

UNIFESP-EPM — Neuromuscular Diseases

Pain relief in all patients and disappearance of pain in 4 of 13.

Design: Whole-body Dome chamber (infrared 4–14 µm), twice weekly, VAS Sample: 13 patients with confirmed neuropathic pain Ramos PE, Abe GC, Oliveira ASB

Bioceramic biostimulation in fibromyalgia

Universidade do Vale do Paraíba (Univap) — Bioengineering

Reduced pain at tender points and improved sleep, with greater improvement than placebo across fatigue, stiffness, paresthesia and swelling.

Design: Controlled study — Body Dome + garments, 6 weeks Sample: 23 women (14 treated / 9 control) Brenneisen dos Santos AN
03

Skin & cellulite

ANVISA/MS 80104760003

Invel® Actiive Shorts — improvement of gynoid lipodystrophy (cellulite)

L.A.L. Clínica de Pesquisa; InfraRedMed; Statpharm

Average 19% improvement in grade II–III cellulite; relative chance of improvement 111% greater than placebo (RR = 2.107), with better skin elasticity and perfusion; safe.

Design: National, randomized, double-blind, placebo-controlled Sample: 151 women, grade III cellulite, 60 days Doi RM, Brioschi ML, Wada CY
Peer-reviewed · USA

Bioceramic fabric for cellulite — published in the Journal of Drugs in Dermatology

Dermatology/Cosmetic Laser Associates of La Jolla, California, USA · 2004

Up to 65% improvement in thighs treated with the bioceramic fabric; 76% of volunteers showed cellulite improvement.

Design: Randomized, double-blind, with/without occlusion Sample: 20 volunteers, moderate cellulite, 4 weeks Rao J, Paabo K, Goldman MP

Comparative anti-cellulite study: bioceramic shorts vs cream vs lymphatic drainage

Kosmoscience; UFSCar; UNESP-Araraquara

The Invel Actiive Shorts produced significant cellulite improvement comparable to cream and manual lymphatic drainage, improving local microcirculation.

Design: Objective assessment — thermography, profilometry, anthropometry Sample: 24 women, stage II cellulite, 30 days Terci D, Pinheiro AS, Alves ALT, Terci DBL, Pinheiro TAL, Longo VM, Longo E
04

Sleep

BIIO-SLEEP bioceramic mattress and sleep quality in post-polio syndrome

UNIFESP-EPM — Neuromuscular Diseases & Psychobiology (Sleep Medicine)

Significant improvement in sleep-quality measures, daytime sleepiness and pain (60% vs 39% reporting less pain).

Design: Double-blind, overnight polysomnography, ~38 days of use Sample: 56 patients (26 treatment / 28 placebo) Silva TM, Quadros AAJ, Moreira GA, Pradella-Hallinan M, Tufik S, Oliveira ASB

Bioceramic garments and mattress in post-poliomyelitis syndrome

UNIFESP-EPM — Neuromuscular Diseases & Psychobiology; InfraRedMed

Significant pain improvement in all patients and better sleep quality; improvement in cold intolerance and periodic limb movement index (p = 0.03).

Design: Polysomnography + infrared imaging, 4 weeks (mattress, shirt, thigh sleeve) Sample: 12 patients (PPS, Mulder criteria) Silva TM, Brioschi ML, Hirata M, Quadros AAJ, Moreira GA, Tufik S, Oliveira ASB
05

Mechanism & thermography

Long infrared radiation on wound healing (experimental model)

Universidade do Vale do Paraíba (Univap) — IP&D

Long infrared reduced early signs of inflammation (edema, exudate) markedly sooner than control, consistent with increased capillary and lymphatic drainage.

Design: Controlled experimental study (infrared vs microcurrent vs control) Sample: Experimental model, 24–72 h follow-up Sonnewend D, Oliveira JLR, Nicolau RA, Magalhães RG, Conrado LA, Zângaro RA, Pacheco MTT

Infrared thermography of skin perfusion under Invel® Bioceramics fabric

InfraRed Med — Infrared Imaging, Hospital 9 de Julho, São Paulo

One hour of use increased cutaneous irrigation and mean skin temperature (+0.82 °C), improving perfusion in both under-perfused (fat) and inflamed tissue.

Design: Infrared imaging of arteriovenous shunts before/after wearing the fabric Sample: Thermographic case series Brioschi ML

Actiive Shirt in inflammatory pain — infrared thermography

InfraRed Med — Infrared Imaging, Hospital 9 de Julho, São Paulo

After 20 minutes wearing the shirt, the inflamed shoulder cooled by 2.2 °C with homogenization of the thermal pattern — the fabric raises perfusion in poorly-vascularized tissue and normalizes it in inflamed tissue.

Design: Infrared imaging before and after 20 minutes of use Sample: Case study — right-shoulder tendinitis Brioschi ML

Invel® moisturizing lotion — cutaneous microvascular effect

InfraRed Med — Infrared Imaging, Hospital 9 de Julho, São Paulo

Unlike common moisturizers, which cool the skin, the Invel lotion (alumina, silica, magnesium) kept cutaneous microvascular perfusion more stable and hydrated the skin for longer.

Design: Infrared imaging, 5 volunteers, every 5 min up to 30 min Sample: 5 volunteers — lower back and thoracic skin Brioschi ML

Actiive Insole — microcirculatory blood distribution by infrared

InfraRed Med — Infrared Imaging, Hospital 9 de Julho, São Paulo

The Invel insole warmed the foot by 3 °C versus a conventional insole and cooled an inflamed toe by 2.5 °C, improving microcirculatory blood distribution to the foot.

Design: Infrared imaging — conventional insole vs Invel insole, before / 1 h after Sample: Comparative case — soles of the feet Brioschi ML

Bioceramic bandage on pain and edema in varicose veins

InfraRed Med — Infrared Imaging, Hospital 9 de Julho, São Paulo

Pain fell from 8 to 2 on the VAS, with reduced venous stasis and lymphatic leakage — less edema and pain in the lower limbs.

Design: Infrared imaging + VAS — bandage ≥8 h/day for 12 days, then Dome sessions (52 days) Sample: Lower-limb varicose veins Brioschi ML
06

Aesthetic (Dome)

France

Invel® Face Dome — facial wrinkles and expression lines

Biophyderm — Cap Alpha, Montpellier, France

Up to 47.37% reduction of wrinkles in the eye area, with a more homogeneous skin relief, using the Invel Face Dome.

Design: Skin profilometry, before / after 15 sessions (with collagen/elastin creams) Sample: Facial skin — crow's-feet area Agopian-Simoneau L, MD (Dermatologist)

Long infrared after liposuction (post-operative)

Brazilian Society of Plastic Surgery (SBCP) — Invel® Body Dome

Faster reduction of post-op edema, quicker weight regression, less pain (fewer painkillers) and less ecchymosis and fibrosis after liposuction, using the Invel Body Dome.

Design: 60 patients, daily for 15 days then 3×/week, with manual lymphatic drainage Sample: 60 post-liposuction patients, 16–42 years Rinaldi AE (SBCP), Pinheiro AF, Alves DG, Aprillanti KT
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Publications & press

WALT 2004 — World Association for Laser Therapy congress. Poster PP127: "Treatment of neuropathic pain with bioceramics" (Conrado, Ramos, Abe, Oliveira — UNIFESP-EPM / INVEL-DOME).

Revista DOR — journal of the Brazilian Society for the Study of Pain (SBED). Vol. 8, no. 4, 2007 (ISSN 1806-0013).

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Journal of Drugs in Dermatology (Rao, Paabo, Goldman) — cellulite, La Jolla, USA, 2004.

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Low-level laser therapy congress proceedings (2003).

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XII Congresso Paulista de Obstetrícia e Ginecologia (2007).

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Larousse Médical.