Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery.

Phase 1

• Conditions: Reconstructive skin surgery in basal cell cancer (Mohs surgery).; MedDRA version: 21.1Level: LLTClassification code: 10064974Term: Mohs micrographic surgery Class: 10042613; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2024-515235-29-00
• Lead Sponsor: Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-03
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients that give their informed consent for study participation., Adult (18 years of age or older), of any sex and racial origin., Clinical and dermatoscopic diagnosis of basal cell carcinoma with lesions on the scalp, torso or extremities, within a certain size that do not allow for surgical closure by direct suture or flaps., Namely, indication for Mohs surgery., Women with childbearing age or men capable of producing a child, should commit to use contraceptives of medically proven efficacy.

Exclusion Criteria

Locally advanced basal cell carcinoma with evidence of deep tissue infiltration (fascia, muscle…)., Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up., Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies., Lesions in the face., except for frontal-lateral area and the temple., Injuries requiring urgent surgical intervention., Infected, necrotic, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft., Injuries that have received treatment with radiotherapy., Contraindication for Mohs surgery., Known allergies to antibiotics that could be part of the impurities in the PHA manufacturing process (gentamicin and amphotericin B)., Pregnant or breastfeeding women., Coagulation disorders that make the healing process of the injury difficult.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified