Artificial skin treatment for basal cell carcinoma patients needing surgery

Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma

This study is testing a new artificial skin treatment for patients with basal cell carcinoma who need surgery to see if it helps them heal better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Andalusian Network for Design and Translation of Advanced Therapies (Academic / other)
• Locations: 4 sites (Marbella, Málaga and 3 other locations)
• Trial ID: NCT05234658 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the safety and efficacy of a tissue-engineered autologous skin substitute for patients with basal cell carcinoma undergoing reconstructive surgery. The study focuses on patients who have lesions that cannot be closed by direct suture or flaps, indicating the need for Mohs surgery. Participants will receive an intervention involving a skin autograft or a specific treatment known as PHITAH. The trial aims to assess how well this innovative approach can aid in healing and recovery.

Who should consider this trial

Good fit: Ideal candidates are adults with basal cell carcinoma lesions on the scalp, torso, or extremities that require reconstructive surgery.

Not a fit: Patients with locally advanced basal cell carcinoma, facial lesions, or those requiring urgent surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing outcomes and reduce complications for patients undergoing surgery for basal cell carcinoma.

How similar studies have performed: Other studies have shown promise with similar tissue-engineered approaches, but this specific application is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients that give their informed consent for study participation.
2. Adult (18 years of age or older), of any sex and racial origin.
3. 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.
4. Women with childbearing age or men capable of producing a child, should commmit to use contraceptives of medically proven efficacy.

Exclusion Criteria:

1. Locally advanced basal cell carcinoma with evidence of tissue infiltration.
2. Lesions in the face.
3. Injuries requiring urgent surgical intervention.
4. Infected lesions, necrosis, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft.
5. Injuries that have received treatment with radiotherapy.
6. Contraindication for Mohs surgery.
7. Known allergies to Biobrane dressing.
8. Pregnant or breastfeeding women.
9. Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up.
10. Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.

Where this trial is running

Marbella, Málaga and 3 other locations

• Hospital Costa del Sol — Marbella, Málaga, Spain (Recruiting)
• Hospital U. Virgen de las Nieves — Granada, Spain (Recruiting)
• Hospital U. Virgen de la Victoria — Málaga, Spain (Recruiting)
• Hospital U. Virgen Macarena — Sevilla, Spain (Recruiting)

Study contacts

• Study coordinator: Macarena Guijo Molero

Conditions Basal Cell Carcinoma