Clinical efficacy and safety of sequential therapy with cryotherapy and topical tirbanibulin 1% in actinic keratoses in transplant recipients: a randomised clinical trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Clinica Universidad De Navarra

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

6 May 2024 → 16 Dec 2024

Decision date (initial)

2024-03-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

ALMIRALL S.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of sequential treatment with cryotherapy and topical tirbanibulin (1%) for actinic keratosis (AK) in solid organ transplant (SOT) patients.

Secondary objectives 3

1. To evaluate the safety of sequential treatment with cryotherapy and topical 1% tirbanibulin for AK in SOT.
2. To evaluate the incidence of new-onset AK on the side treated sequentially with cryotherapy and tirbanibulin compared to the side treated with cryotherapy alone, thus estimating the efficacy in the cancerisation field.
3. Compare the difference in quality of life, satisfaction, and patient preference between the use of cryotherapy and the sequential treatment of cryotherapy and tirbanibulin.

Conditions and MedDRA coding

Actinic keratosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Solid organ transplant patients with AK
2. Time elapsed since the transplant of at least one year.
3. Stable immunosuppressive treatment for at least 6 months.
4. Presence of 4 to 8 AKs in two symmetrical areas of 25 cm2 (in the contralateral facial area or scalp) susceptible to treatment.
5. The patient must be 18 years or older.
6. The patient, or his or her representative, has given consent to participate in the study.
7. The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
8. In the case of women of childbearing potential, they must agree to use a safe means of contraception (abstinence is considered an acceptable method) for the entire treatment period and for at least one more month. A negative pregnancy test will be required on the selection date.

Exclusion criteria 5

1. History of hypersensitivity to the active substances of the medication or any of its excipients.
2. Use of oral retinoids, nicotinamide or oral capecitabine.
3. Diagnosis or suspicion of EC in any of the areas to be treated
4. Physical treatment (cryotherapy, curettage, electrosurgery, laser) or pharmacological treatment (chemical peels, photodynamic therapy, 5-fluorouracil, imiquimod, tirbanibulin) in the 3 months prior to inclusion in the trial.
5. Women who are pregnant, lactating, or planning pregnancy during treatment with tirbanibulin. Once the treatment period has ended, pregnancy will not be a criterion for withdrawal from the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy end point is the percentage change in the number of AKs on the side treated with cryotherapy + tirbanibulin at 3 months of follow-up, compared to the side treated with cryotherapy alone.

Secondary endpoints 5

1. Percentage of patients with a complete response (100%) in the reduction in the number of lesions and a partial response (greater than or equal to 75%) in the reduction in the number of lesions in V(3) on the side treated with cryotherapy + tirbanibulin, compared to the side only treated with cryotherapy.
2. Differences in the number of new and persistent AKs in V(3) between the area treated with cryotherapy + tirbanibulin and the area treated with cryotherapy alone.
3. Number of local skin reactions and tolerance to treatment on each side.
4. Differences in quality of life scales (comparing each side in V(3) with visit V(0), patient satisfaction and preference between both sides in V(3).
5. Description of persistent AKs according to Olsen grade (percentage of grade I, grade II and grade III).

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Clinica Universidad De Navarra

Sponsor organisation

Clinica Universidad De Navarra

Address

Avenue Pio XII 36

City

Pamplona

Postcode

31008

Country

Spain

Scientific contact point

Organisation

Clinica Universidad De Navarra

Contact name

UCEC

Public contact point

Organisation

Clinica Universidad De Navarra

Contact name

UCEC

Locations

1 EU/EEA country · 1 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

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

Application history

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