Type 1 diabetes mellitus
Conditions
Interventions
This is a ten-arm, single-blind randomised controlled clinical study. First stage of the study: 80 healthy women aged between 18 and 56, randomly divided into four groups (A, B, C and D) of 20 partici
Group B: three areas treated with the emollients caprylic and capric acid triglyceride (TACC), dodecane and sweet almond oil, one area treated with solid petroleum jelly and one untreated area (contro
Group C: two areas treated with the emollients soya lecithin and castor oil, one area treated with solid petroleum jelly and one area not treated (control)
Group D: three areas treated with the emollients pecan seed oil, sunflower seed oil and isopropyl palmitate, one area treated with solid petroleum jelly and one area not treated (control). Transepider
Group B: the following samples were applied: 1,3-propanediol 10%, 1,3-propanediol 10% +
Sponsors
Faculdade de Ciências Farmacêuticas da Universidade Estadual de Campinas
Kosmoscience Ciência e Tecnologia Cosmética Importação e Exportação Ltda
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: First and second stages of the study - 18 to 60 years old; female; phototype I to VI; normal to dry body skin; intact skin in the study area; agree to comply with the procedures and requirements of the study; sign the Free and Informed Consent Form. Third stage of the study - 60 to 90 years old; both genders; phototype I to VI; agree to comply with the procedures and requirements of the study; sign the Informed Consent Form. Fourth stage of the study - 60 to 90 years old; both genders; phototype I to V; 50% of the panel (25 participants with type I or II diabetes mellitus) and 50% of the healthy panel; agree to comply with the procedures and requirements of the study; agree not to undergo dermatological and/or aesthetic body treatments until the end of the study; sign the Free and Informed Consent Form
Exclusion criteria
Exclusion criteria: History of allergic reactions, irritation or intense sensations of discomfort to topical products: cosmetics or medicines. Skin markings in the experimental area that interfere with the assessment of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, large freckles and warts, sunburn). Patients unable to return for a clinical evaluation. Presence of active dermatoses (local or disseminated) that could interfere with the results of the study. Use of non-hormonal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizers or immunosuppressants up to 2 weeks before the study. Intense sun exposure or tanning sessions up to 15 days before the initial assessment. Aesthetic or dermatological body treatment up to 4 weeks before the study. Hormonal treatments that have not been stable in the last 3 months. People directly involved in carrying out this study and their families. Participating in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is hoped that the O/W emulsion-type cosmetic formulation developed in the research project will be effective in improving hydration, reducing water loss and skin roughness, improving skin firmness and elasticity, improving the thickness and echogenicity of the dermis, helping to prevent and treat dermatoporosis in diabetic and healthy participants | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe a statistically superior or statistically equal performance of the cosmetic formulation developed in the research project, compared to the market reference moisturising product | — |
Countries
Brazil
Contacts
Public ContactJuliana Pinto
Faculdade de Ciências Farmacêuticas da Universidade Estadual de Campinas
Outcome results
None listed