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

Study Overview
=================
Brief Summary
-----------------
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma

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

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Biological: PHITAH
* Biological: PHIT
* Biological: Skin Autograft


Participation Criteria
=================
Eligibility Criteria
-----------------
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 commmit to use contraceptives of medically proven efficacy. Exclusion Criteria: Locally advanced basal cell carcinoma with evidence of tissue infiltration. Lesions in the face. Injuries requiring urgent surgical intervention. Infected lesions, necrosis, 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 Biobrane dressing. Pregnant or breastfeeding women. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PHIT<br>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). | Biological: PHIT<br>* Human artificial skin created by tissue engineering: fibrin-agarose<br>|
| Experimental: PHITAH<br>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). | Biological: PHITAH<br>* Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid<br>|
| Active Comparator: Skin Autograft<br>Skin autograft. | Biological: Skin Autograft<br>* Skin Autograft<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of autologous bioengineered skin | Incidence of adverse events related to investigational medicinal products | Through study completion, an average of 2 year | 
| Efficacy of autologous bioengineered skin | Satisfaction of the graft assessed by doppler ultrasound and study of homeostasis | Through study completion, an average of 2 year |