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Tests are being conducted to verify if the product Hycos Reparador EB is effective and safe for people with Epidermolysis Bullosa (EB)

Single-blind clinical study of the efficacy and safety of the product Hycos Reparador EB

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7kc6rrx
Enrollment
Unknown
Registered
2024-11-18
Start date
2024-01-11
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Healing

Interventions

Proof of efficacy and safety of the product Hycos Reparador EB, formulated for patients diagnosed with Edidermolysis Bullosa (EB). The study was conducted as a single-group, single-blind clinical tria
E04.987

Sponsors

Instituto de Saúde e Bem Estar da Mulher
Lead Sponsor
Nipo Serviços Médicos SS Ltda
Collaborator

Eligibility

Age
12 Months to No maximum

Inclusion criteria

Inclusion criteria: Patients of both sexes. Age over 12 months. All skin types

Exclusion criteria

Exclusion criteria: Pregnancy and/or lactation. Immunodeficiency. Use of systemic corticosteroids. History of reaction to the category of the product tested. Other diseases or medications that may directly interfere with the study or pose a risk to the volunteer's health

Design outcomes

Primary

MeasureTime frame
Demonstrate the efficacy of Hycos Reparador EB in humans, including the pediatric and adolescent population—

Secondary

MeasureTime frame
No secondary outcomes are expected—

Countries

Brazil

Contacts

Public ContactFrederico Viana

TCI Laboratório Biotecnológico Ltda

frederico@tcilab.com.br+55 38 99886-3565

Outcome results

None listed

Source: REBEC (via WHO ICTRP)