Efficacy and Safety of Cryotherapy followed by Tirbanibulin ointment for actinic keratosis on the scalp and forehead

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Lille

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Decision date (initial)

2024-06-28

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

ALMIRALL

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Assess the efficacy at 8 months of a combined approach associating cryotherapy and tirbanibulin, repeated at 4 months (only if persistent keratosis with regard to cryotherapy) on actinic keratosis of the scalp.

Secondary objectives 6

1. Assess the efficacy at 12 months of a combined approach associating cryotherapy and tirbanibulin, repeated at 4 and 8 months (only if persistent keratosis with regard to cryotherapy) on actinic keratosis of the scalp.
2. Assess the reduction of the number of actinic keratosis after two cycles of treatment.
3. Assess the reduction of the number of actinic keratosis after three cycles of treatment.
4. Evaluate the reduction in the use of cryotherapy with tirbanibulin.
5. Safety and tolerance descritpion by side treated at each follow-up visit
6. Delineate the area affected by subclinical actinic keratosis (cancer field concept).

Conditions and MedDRA coding

Patients (male or female) ≥18 years old with scalp and forehead actinic keratoses

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patient ≥ 18 years old with Scalp containing ≥ 8 typical, clinically visible or palpable grade I or II actinic keratosis with at least 4 actinic keratosis per hemi-scalp.
2. Patient who, according to the investigator's opinion, are in good general condition (WHO ≤2).
3. The actinic keratosis must be distributed in 2 non-overlapping zones of similar grade.
4. Patient able to understand and agree to the study visit schedule and other protocol requirements.
5. Patient able to understand and voluntarily sign an informed consent form.
6. Patient with social insurance.
7. Patient willing to comply with all study procedures and study duration.

Exclusion criteria 8

1. Actinic keratosis clinically atypical and/or rapidly progressive in the treatment area, and grade 3 actinic keratosis according to Olsen's classification.
2. A defined treatment area, which would be : - On an area other than the scalp and/or forehead. - Within 5 cm of a wound that has not completely healed or a lesion suspected of containing carcinoma.
3. Previous treatment with Tirbanibulin.
4. Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatment for actinic keratosis in the treatment area, or within 2 cm around this area, in the 6 weeks prior to the screening visit.
5. Use of the following therapies within 2 weeks prior to the screening visit: - Therapeutic or cosmetic procedures (e.g. use of liquid nitrogen, surgical excision, dermabrasion, medium or deep chemical peel, laser resurfacing) in the treatment area or within 2 cm around the selected treatment area. - Therapeutic products containing acid (e.g. salicylic acid, fruit acids, etc.), topical retinoids, or light peels in the treatment area or within 2 cm around the selected treatment area.
6. Allergy to tirbanibulin or any of its components.
7. Any pathology entailing a risk of poor compliance.
8. Administrative reasons: inability to receive informed information, inability to take part in the entire study, lack of social security cover, refusal to sign consent, etc.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Complete response rate of actinic keratosis at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.

Secondary endpoints 6

1. Complete response rate for actinic keratosis at 12 months.
2. Partial response rate (= 75% reduction of lesions) at 8 months.
3. Partial response rate (= 75% reduction of lesions) at 12 months.
4. Number of cryotherapy sessions carried out over the follow-up period.
5. Collection of the following local skin reactions: erythema, desquamation, crusts, oedema, vesicles/pustules, erosions/ulcerations and gradation on a scale from 0 to 3: 0=absent, 1=light (barely perceptible), 2=moderate (obvious presence), 3=severe (marked, intense). Assessment of pain using a visual analogue scale from 0 to 10.
6. The photographs taken during the visits will be analysed using computer-aided image processing.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Lille

Sponsor organisation

Centre Hospitalier Universitaire De Lille

Address

2 Avenue Oscar Lambret, Cs 70001 Cs 70001

City

Lille Cedex

Postcode

59037

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Lille

Contact name

Pr. Laurent MORTIER

Public contact point

Organisation

Centre Hospitalier Universitaire De Lille

Contact name

Pr. Laurent MORTIER

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

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

Documents 3 files

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

Application history

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