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A portable irradiation device for the improvement of photodinamic therapy

A portable device for photodynamic Therapy to improve treatment reducing the time under treatment at the hospital

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
REBEC
Registry ID
RBR-10z7j4jd
Enrollment
Unknown
Registered
2021-12-29
Start date
2022-01-01
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

basal cell carcinoma

Interventions

280 nodular and superficial basal cell carcinoma (BCC) lesions will be included in this study. These lesions will be randomized into four different groups, with the same number of lesions (70 lesions
Groups A2 and B2: use of a portable prototype. In Groups A1 and A2, nodular BCC type lesions will be treated, while Groups B1 and B2 superficial BCC type lesions will be treated. The sequence of proce
E02.774.722

Sponsors

Instituto de Física de São Carlos
Lead Sponsor
Hospital Amaral Carvalho
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: both sexes; older than 18 years; basal cell carcinoma lesions with less than 2 cm diameter; patients presenting multiple lesions can be included if the lesions have less than 2 cm diameter.

Exclusion criteria

Exclusion criteria: allergies from any compound of the formula; infiltrative or sclerodermiform basal cell carcinoma, as well as other skin cancers like squamous cell carcinoma or melanoma; patients with pophyria diagnosis; basal cell carcinoma lesions larger than 2 cm; patients under 18; pregnant or lactating women; women at the childbearing age; photossensitive diseases.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1 - Evaluation of the cure rate of Photodynamic Therapy using the portable device in the treatment of basal cell carcinoma analysing the biopsy performed 30 days after treatment

Secondary

MeasureTime frame
Expected outcome 3- Assessment of pain score and patient preference.;Expected outcome 2 - recurrence at 12 months

Countries

Brazil

Contacts

Public ContactAna Salvio

Hospital Amaral Carvalho

gasalvio@hotmail.com+55 (014) 36021200

Outcome results

None listed

Source: REBEC (via WHO ICTRP)