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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

9 Jul 2024 → ongoing

Decision date (initial)

2024-07-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515235-29-00

EudraCT number

2018-004738-14

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Safety: To confirm that the use of nanostructured autologous artificial skin based on a fibrin matrix combined with agarose or hyaluronic acid is safe, based on the incidence of adverse events related to the investigational products, both during their implantation, as during subsequent follow-up.
Feasibility: To verify that the surgical implant with nanostructured autologous artificial skin based on a fibrin matrix combined with agarose or hyaluronic acid is feasible in terms of its suturability and ability to attach to the recipient tissue, maintain its integrity and facilitate the re-epithelialization of the surgical wound.

Secondary objectives 8

1. To analyze whether the investigational medicinal products have an efficacy (% epithelialization 21 days after surgery) similar or superior to the use of autografts in reconstructive surgery for basal cell carcinoma (Mohs surgery).
2. Clinical safety evaluation of the new treatment in relation to autografts, analyzing the possible adverse effects associated with its use, as well as the degree of adhesion of the graft in the first cure, the presence of infections or necrosis or other complications, or the percentage of epithelialization at three weeks and throughout the follow-up period.
3. Compare histologically (optical microscopy and immunohistochemical studies) the PHA bioimplanted in the patient and the autograft 4 weeks after implantation, taking as reference the samples of healthy human skin and the PHA itself in vitro.
4. Study skin homeostasis (pH, temperature, transepidermal water loss, elasticity) prospectively in the three groups of the clinical trial using a system of non-invasive probes, using the patient's own measurements in the untreated area as reference measurements.
5. Analyze the ultrasound differences in the three arms of the study that allow the characteristics of the dermis and epidermis to be studied in vivo.
6. Compare the safety of PHA in relation to autograft, in terms of the pain generated by the intervention, considering both the surgical lesion and the donor area (when applicable).
7. Analyze the aesthetic quality of the scar (POAS questionnaire) in the three treatment groups, as well as its impact on the patient's quality of life (DLQI and SCI questionnaires).
8. Carry out a comparative economic evaluation study between the three types of treatments used in the clinical trial.

Conditions and MedDRA coding

Reconstructive skin surgery in basal cell cancer (Mohs surgery).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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.
4. Namely, indication for Mohs surgery.
5. Women with childbearing age or men capable of producing a child, should commit to use contraceptives of medically proven efficacy.

Exclusion criteria 11

1. Locally advanced basal cell carcinoma with evidence of deep tissue infiltration (fascia, muscle…).
2. Lesions in the face., except for frontal-lateral area and the temple.
3. Injuries requiring urgent surgical intervention.
4. Infected, necrotic, 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 antibiotics that could be part of the impurities in the PHA manufacturing process (gentamicin and amphotericin B).
8. Pregnant or breastfeeding women.
9. Coagulation disorders that make the healing process of the injury difficult.
10. Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up.
11. Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Safety: adverse events and adverse reactions, including complications and sequelae in the healing of the surgical injury, making a distinction between early sequelae (hematoma, infection, blistering and graft loss) and late sequelae (necrosis, inflammation, granulation, abnormal healing, retractions, residual ulcers, pigmentation disorders...). Safety variables will be measured both in the surgical lesion and in the donor area, when applicable.
2. Feasibility: surgical suturability, and ability to grasp/adhere to the recipient tissue in the first healing, maintain its integrity and facilitate re-epithelialization of the surgical wound.

Secondary endpoints 3

1. Efficacy: Percentage of epithelialization of the lesion 3 weeks after the intervention, time until removal of stitches, time until complete epithelialization. Degree of pain (based on a visual analogue scale and analgesic use data). Aesthetic appearance of the lesion according to the POSAS scale (Van de Kar AL, 2005). Quality of life according to the DLQI indices (Finlay AY, 1994) and the SCI (Rhee JS, 2006; Rhee JS, 2007). Rescue surgeries performed.
2. Efficacy: Complementarily, a set of structural characteristics, molecular and functional properties of the skin will be measured in the surgical injury using different study techniques: doppler ultrasound, cutaneous homeostasis study, histological tests of skin biopsies using optical microscopy.
3. Economic evaluation: A set of variables will be measured with the objective of comparatively analyzing the efficiency of the three types of treatments used in the clinical trial.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

Sponsor organisation

Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

Address

Edificio S-2, Calle Americo Vespucio Nº 15, Parque Cientifico Y Tecnologico Cartuja 93 Calle Americo Vespucio Nº 15 Parque Cientifico Y Tecnologico Cartuja 93

City

Sevilla

Postcode

41092

Country

Spain

Scientific contact point

Organisation

Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

Contact name

Gloria Carmona Sánchez

Public contact point

Organisation

Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

Contact name

Blanca Quijano Ruiz

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications