Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Almirall, SAS | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The aim of the study is to evaluate the efficacy and safety of a combined approach of cryotherapy and tirbanibulin for the treatment of actinic keratosis of the scalp and forehead, repeated every 4 months. A higher rate of complete response is expected with this combination compared to cryotherapy alone, as well as a better response with repeated treatment cycles.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Cryotherapy + Tirbanibulin : Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months) |
|
| Control group | Placebo Comparator | Cryotherapy + placebo : Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy + Tirbanibulin | Drug | Tirbanibulin ointment applied once daily for 5 days, repeated 3 times (every 4 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete clearance of actinic keratosis | Complete clearance rate of actinic keratoses at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the 12-month effectiveness of a combined approach using cryotherapy and tirbanibulin. | Complete Clearance of Actinic Keratosis at 12 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area. | 12 months |
| To evaluate the reduction in the number of actinic keratoses after 2 treatment cycles. |
Not provided
Inclusion Criteria:
Have a negative pregnancy test at screening and during the treatment period,
Use an effective contraceptive method throughout the study participation. Menopausal women (absence of menstruation for at least one year without other medical cause) or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy) may be enrolled.
Exclusion Criteria:
Clinically atypical and/or rapidly evolving actinic keratoses (AK) in the treatment area, and grade 3 AK according to Olsen classification,
A defined treatment area that would be:
Prior treatment with tirbanibulin,
Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for actinic keratoses in the treatment area or within 2 cm around this area within 6 weeks prior to the screening visit,
Use of the following therapies within 2 weeks prior to the screening visit:
Allergy to tirbanibulin or any of its components.
Any condition causing a risk of poor compliance,
Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign the consent form,
Women of childbearing potential who refuse to use an effective contraceptive method,
Pregnant women, women planning to become pregnant, and breastfeeding women,
Persons deprived of liberty by judicial or administrative decision.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007642 | Keratosis |
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| C000713668 | tirbanibulin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
One single group, each patient serving as their own control, with an intra-individual comparison of one hemiscalp with the contralateral hemiscalp
Not provided
Not provided
One single group, each patient serving as their own control, with an intra-individual comparison of one hemiscalp with the contralateral hemiscalp
|
Partial clearance rate (75% reduction in the number of actinic keratoses) at 8 months. |
| 8 months |
| To evaluate the reduction in the number of actinic keratoses after 3 treatment cycles. | Partial clearance rate (75% reduction in the number of actinic keratoses) at 12 months. | 12 months |
| To evaluate the reduction in the need for cryotherapy with tirbanibulin. | Number of cryotherapy sessions performed over the entire follow-up period. | 12 months |
| To describe the safety and tolerability by treated side at each follow-up visit. | Safety: Local skin reactions assessed throughout the study | 12 months |