Basal Cell CarcinomaPhase 2NCT05234658
Study of an Artificial Human Skin Medicine for Patients With Basal Cell Carcinoma Undergoing Reconstructive Surgery
A Phase 2 study testing PHITAH, PHIT and Skin Autograft in people with Basal Cell Carcinoma, run by Andalusian Network for Design and Translation of Advanced Therapies at 4 sites in Spain.
Trial summary
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- PHITAH, PHIT and Skin Autograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesSpain
- Study dates
- 21 Jan 2022to 1 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 4 recruiting
- Recruiting
Hospital U. Virgen de las Nieves
Granada, 18014
Salvador Arias
- Recruiting
Hospital U. Virgen de la Victoria
Málaga, 29010
Ricardo Bosch
- Recruiting
Hospital Costa del Sol
Marbella, Málaga, 29603
Magdalena Troya
- Recruiting
Hospital U. Virgen Macarena
Seville, 4109
David Moreno
About this study
Official title: Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
- Conditions
- Basal Cell Carcinoma
- Being tested
- PHITAH, PHIT, Skin Autograft
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHITAHBiological
Tissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid
PHITBiological
Human artificial skin created by tissue engineering: fibrin-agarose
Skin AutograftBiological
Skin Autograft
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Biological: PHITAH |
| Skin Autograft | Active comparator | Skin autograft. Receives: Biological: Skin Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of autologous bioengineered skin
Incidence of adverse events related to investigational medicinal products
Measured: 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
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start21 Jan 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andalusian Network for Design and Translation of Advanced Therapies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234658
- Sponsor's protocol ID
- NanoGSkin-CB-2019
- Status last verified
- Nov 2023
- First submitted
- 27 Dec 2021
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05234658
- Acronym / sponsor ID
- NanoGSkin-CB-2019
- Conditions
- Basal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Andalusian Network for Design and Translation of Advanced TherapiesUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PHIT | Experimental | Biological: PHITHuman 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). |
| PHITAH | Experimental | Biological: PHITAHHuman 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). |
| Skin Autograft | Active comparator | Biological: Skin AutograftSkin autograft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHITAHTissue Engineered Human Artificial Skin: Fibrin-Hyaluronic Acid | Biological | PHITAH |
| PHITHuman artificial skin created by tissue engineering: fibrin-agarose | Biological | PHIT |
| Skin AutograftSkin Autograft | Biological | Skin Autograft |
Primary outcome
Safety of autologous bioengineered skin
Time frame: Through study completion, an average of 2 year
Incidence of adverse events related to investigational medicinal products
Efficacy of autologous bioengineered skin
Time frame: Through study completion, an average of 2 year
Satisfaction of the graft assessed by doppler ultrasound and study of homeostasis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PHITAH, PHIT and Skin Autograft in people with Basal Cell Carcinoma, run by Andalusian Network for Design and Translation of Advanced Therapies at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Macarena Guijo Molero (671 537 264 ext. 0034, macarena.guijo@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of autologous bioengineered skin (time frame: Through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.