NCT05234658

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2022

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

January 21, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

December 27, 2021

Last Update Submit

November 7, 2023

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

PHIT

EXPERIMENTAL

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

PHITAH

EXPERIMENTAL

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

Skin Autograft

ACTIVE COMPARATOR

Skin autograft.

Biological: Skin Autograft

Interventions

PHITAHBIOLOGICAL

Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid

PHITAH
PHITBIOLOGICAL

Human artificial skin created by tissue engineering: fibrin-agarose

PHIT
Skin AutograftBIOLOGICAL

Skin Autograft

Skin Autograft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Costa del Sol

Marbella, Málaga, 29603, Spain

RECRUITING

Hospital U. Virgen de las Nieves

Granada, 18014, Spain

RECRUITING

Hospital U. Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Hospital U. Virgen Macarena

Seville, 4109, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Central Study Contacts

Macarena Guijo Molero

CONTACT

671 537 264macarena.guijo@juntadeandalucia.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2021

First Posted

February 10, 2022

Study Start

January 21, 2022

Primary Completion

January 1, 2024

Study Completion

December 1, 2024

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)