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

Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05234658
• Other study ID #: NanoGSkin-CB-2019
• Status: Recruiting
• Phase: Phase 2
• Start date: January 21, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Andalusian Network for Design and Translation of Advanced Therapies
• Contact: Macarena Guijo Molero
• Phone: 671 537 264
• Email: macarena.guijo[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Biological:
• PHITAH
Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid
• PHIT
Human artificial skin created by tissue engineering: fibrin-agarose
• Skin Autograft
Skin Autograft

Locations

Country	Name	City	State
Spain	Hospital U. Virgen de las Nieves	Granada
Spain	Hospital U. Virgen de la Victoria	Málaga
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital U. Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Andalusian Network for Design and Translation of Advanced Therapies

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of autologous bioengineered skin	Incidence of adverse events related to investigational medicinal products	Through study completion, an average of 2 year
Primary	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