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

Phase 2

Recruiting

• Conditions: Basal Cell Carcinoma
• Interventions: Biological: PHITAH; Biological: PHIT; Biological: Skin Autograft

• Registration Number: NCT05234658
• Lead Sponsor: Andalusian Network for Design and Translation of Advanced Therapies

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-27
• Study Start: 2022-01-21
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08
• Primary Completion: 2024-01-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PHITAH	PHITAH	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).
PHIT	PHIT	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).
Skin Autograft	Skin Autograft	Skin autograft.

Primary Outcome Measures

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

Trial Locations

Locations (4)

Hospital Costa del Sol; 🇪🇸 Marbella, Málaga, Spain

Hospital U. Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital U. Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital U. Virgen de la Victoria; 🇪🇸 Málaga, Spain