Clincosm LogoSign in Get a demo

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

Sponsor
Andalusian Network for Design and Translation of Advanced Therapies (Other)
Overall Status
Recruiting
CT.gov ID
NCT05234658
Collaborator
(none)
28
Enrollment
4
Locations
4
Arms
34.3
Anticipated Duration (Months)
7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: PHITAH
  • Biological: PHIT
  • Biological: Biobrane
  • Biological: Autograft
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Actual Study Start Date :
Jan 21, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: PHIT

Biological: PHITAH
Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid
Experimental: PHITAH

Biological: PHIT
Human artificial skin created by tissue engineering: fibrin-agarose
Active Comparator: Biobrane

Biological: Biobrane
Silicone and collagen dressing
Active Comparator: Autograft

Biological: Autograft
Autograft

Outcome Measures

Primary Outcome Measures

  1. Safety of autologous bioengineered skin [Through study completion, an average of 2 year]

    Incidence of adverse events related to investigational medicinal products

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Costa del Sol Marbella Málaga Spain 29603
2 Hospital U. Virgen de las Nieves Granada Spain 18014
3 Hospital U. Virgen de la Victoria Málaga Spain 29010
4 Hospital U. Virgen Macarena Sevilla Spain 4109

Sponsors and Collaborators

  • Andalusian Network for Design and Translation of Advanced Therapies

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andalusian Network for Design and Translation of Advanced Therapies
ClinicalTrials.gov Identifier:
NCT05234658
Other Study ID Numbers:
  • NanoGSkin-CB-2019
First Posted:
Feb 10, 2022
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell

Study Results

No Results Posted as of Feb 10, 2022