Study of an artificial human skin medicine for patients with basal cell carcinoma undergoing reconstructive surgery.

PHASE II CLINICAL TRIAL EVALUATING THE SAFETY AND EFFICACY OF A TISSUE ENGINEERED AUTOLOGOUS SKIN SUBSTITUTE RECONSTRUCTIVE SURGERY FOR BASAL CELL CARCINOMA.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004738-14-ES

Enrollment

Registered

2020-01-10

Start date

2020-04-28

Completion date

Unknown

Last updated

2020-09-28

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

Conditions

Reconstructive skin surgery in basal cell cancer (Mohs surgery) MedDRA version: 20.0 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10064974 Term: Mohs micrographic surgery System Organ Class: 100000004865

Interventions

Product Name: Adult autologous skin keratinocytes and fibroblasts expanded on fibrin-hialuronic biological matrix Product Code: NanoGSkin Pharmaceutical Form: Implant INN or Proposed INN: EX-VIVO EXPA

Eligibility

Sex/Gender

All

Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the safety and effectiveness of autologous bioengineered skin in reconstructive surgery for basal cell carcinoma (Mohs surgery), in comparison with skin autografts and silicone dressings (Biobrane ®);Secondary Objective: - Clinical safety evaluation including any adverse events such as graft detachment, infections, necrosis, or other events. - Histological evaluation of the skin in the surgical injury. - Study of cutaneous homeostasis (pH, temperature, transepidermal water loss, elasticity) of the skin in the surgical injury. - Ultrasound study of the skin in the surgical injury. - Cost-effectiveness study of terapeutic alternatives evaluated in the trial (autologous skin substitute, autografts and biobrane).;Primary end point(s): SAFETY ENDPOINTS: adverse events, including complications and sequelae in the healing of the surgical injury, as well as the severity of pain (analogical visual scale and use of analgesics). Both the surgical injury and the donor area (when applicable) will be taken into account in the evaluation. EFFICACY ENDPOINTS: clínical progress and time to complete epithelialization of the injury, time to removal of the suture, aesthetic quality of the lesion (POSAS questionnaire) and quality of life (DLQI). Efficacy variables will be measured both in the surgical lesion as well as in the donor area (when applicable).;Timepoint(s) of evaluation of this end point: At baseline and at day 5, 12, 30, 60, 90, 150, 210, 365, 548 and 730 after surgery, acording to the visits and assessments schedule of the trial protocol.	—

Measure

Time frame

Main Objective: Evaluate the safety and effectiveness of autologous bioengineered skin in reconstructive surgery for basal cell carcinoma (Mohs surgery), in comparison with skin autografts and silicone dressings (Biobrane ®);Secondary Objective: - Clinical safety evaluation including any adverse events such as graft detachment, infections, necrosis, or other events. - Histological evaluation of the skin in the surgical injury. - Study of cutaneous homeostasis (pH, temperature, transepidermal water loss, elasticity) of the skin in the surgical injury. - Ultrasound study of the skin in the surgical injury. - Cost-effectiveness study of terapeutic alternatives evaluated in the trial (autologous skin substitute, autografts and biobrane).;Primary end point(s): SAFETY ENDPOINTS: adverse events, including complications and sequelae in the healing of the surgical injury, as well as the severity of pain (analogical visual scale and use of analgesics). Both the surgical injury and the donor area (when applicable) will be taken into account in the evaluation. EFFICACY ENDPOINTS: clínical progress and time to complete epithelialization of the injury, time to removal of the suture, aesthetic quality of the lesion (POSAS questionnaire) and quality of life (DLQI). Efficacy variables will be measured both in the surgical lesion as well as in the donor area (when applicable).;Timepoint(s) of evaluation of this end point: At baseline and at day 5, 12, 30, 60, 90, 150, 210, 365, 548 and 730 after surgery, acording to the visits and assessments schedule of the trial protocol.

—

Secondary

Measure	Time frame
Secondary end point(s): Complementarily, a set of structural characteristics, molecular and functional properties of the skin will be measured in the surgical injury using different study techniques: doppler ultrasound, cutaneous homeostasis study, histological tests of skin biopsies using optical microscopy and immunohistochemical analysis.;Timepoint(s) of evaluation of this end point: At baseline and at day 5, 12, 30, 60, 90, 150, 210, 365, 548 and 730 after surgery, acording to the visits and assessments schedule of the trial protocol.	—

Measure

Time frame

Secondary end point(s): Complementarily, a set of structural characteristics, molecular and functional properties of the skin will be measured in the surgical injury using different study techniques: doppler ultrasound, cutaneous homeostasis study, histological tests of skin biopsies using optical microscopy and immunohistochemical analysis.;Timepoint(s) of evaluation of this end point: At baseline and at day 5, 12, 30, 60, 90, 150, 210, 365, 548 and 730 after surgery, acording to the visits and assessments schedule of the trial protocol.

—

Countries

Spain

Contacts

Public ContactClinical Trial Unit

Red Andaluza de Diseño y Traslación de Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud

terapias.avanzadas@juntadeandalucia.es+3495504 83 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026