Clinical trial · Interventional
Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
NCT05234658CI-TRIAL-00071151unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PHIT | Biological | — | UNRESOLVED |
| PHITAH | Biological | — | UNRESOLVED |
| Skin Autograft | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- PHIT
- description
- 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).
- interventionNames
- Biological: PHIT
- type
- EXPERIMENTAL
- label
- PHITAH
- description
- 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).
- interventionNames
- Biological: PHITAH
- type
- ACTIVE_COMPARATOR
- label
- Skin Autograft
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.