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

Andalusian Network for Design and Translation of Advanced Therapies

Status and phase: Enrolling; Phase 2

Conditions: Basal Cell Carcinoma

Treatments: Biological: Skin Autograft; Biological: PHITAH; Biological: PHIT

Study type: Interventional

Funder types: Other

Identifiers

NCT05234658

NanoGSkin-CB-2019

Details and patient eligibility

About

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

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

PHIT

Experimental group

Description:

Human artificial skin created by tissue engineering, composed of a sheet of autologous adult differentiated skin keratinocytes and fibroblasts expanded in a biological fibrin-agarose matrix (PHIT).

Treatment:

Biological: PHIT

PHITAH

Experimental group

Description:

Human artificial skin created by tissue engineering, composed of a sheet of keratinocytes and differentiated autologous adult skin fibroblasts expanded in a biological fibrin-hyaluronic matrix (PHITAH).

Treatment:

Biological: PHITAH

Skin Autograft

Active Comparator group

Description:

Skin autograft.

Treatment:

Biological: Skin Autograft