Atrophic disorders of skin
Conditions
Interventions
This is a single-blind randomized placebo-controlled clinical trial with an intra-individual paired design involving 61 female participants where all participants received both interventions on opposi
Sponsors
Fundação Oswaldo Cruz
Fundação Oswaldo Cruz
Eligibility
Sex/Gender
Female
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: Female participants; aged between 20 and 80 years; skin phototypes I II or III according to Fitzpatrick classification; presence of intact skin on the forearm region; availability to attend in-person assessments; signed Informed Consent Form
Exclusion criteria
Exclusion criteria: History of hypersensitivity or allergy to formulation components; presence of dermatosis wounds or scars in the test area; use of topical or systemic medications that may interfere with the assessment such as corticosteroids and antihistamines in the last two weeks; pregnancy or breastfeeding; intense sun exposure or use of self-tanners on the forearm region during the study; aesthetic procedures performed on the forearm region in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Change in skin proteomic profile and predicted biological skin age assessed by mass spectrometry and machine learning after 30 days of treatment;Observed outcome 1: Proteomic analysis revealed that quinoa bioester treatment induced a significant reduction in predicted biological skin age compared to placebo. A median reduction in proteomic age of 11 years was observed in participants under 50 and 16 years in participants aged 50 and older (p<0.01). There was a significant increase in the abundance of barrier proteins (desmoglein-1, filaggrin), antioxidant enzymes (SOD1, glutathione synthetase), and protease inhibitors | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: Change in skin hydration levels measured by bioelectrical impedance SkinUp after 30 days of treatment;Observed outcome 2: Skin hydration measured by bioimpedance increased by 1.14 AU in the bioactive group versus 0.54 AU in the placebo group (111% relative improvement), though statistical significance was not reached (p>0.05) | — |
Countries
Brazil
Contacts
Public ContactPaulo Costa Carvalho
Instituto Carlos Chagas (Fiocruz - PR).
Outcome results
None listed