Phase 3
N=105
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis
Keratosis, Actinic
Bottom Line
View on ClinicalTrials.gov: NCT05279131 ↗Enrolled (actual)
105
Serious AEs
1.9%
Results posted
Jan 2024
Primary outcome: Primary: Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 — 81; 19; 5; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tirbanibulin ointment 1% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Almirall, S.A.
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5 |
81; 19; 5; 0; 13; 41 | — |
| PRIMARY Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8 |
81; 19; 5; 0; 9; 32 | — |
| PRIMARY Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15 |
81; 19; 5; 0; 33; 61 | — |
| PRIMARY Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29 |
81; 19; 5; 0; 74; 26 | — |
| PRIMARY Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57 |
81; 19; 5; 0; 95; 7 | — |
| PRIMARY Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) |
81; 19; 5; 0; 4; 27 | — |
| PRIMARY Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration |
4.0; 7.0; 7.0; 4.0; 4.0; 7.0 | — |
| PRIMARY Local Tolerability Signs Total Composite Score by Visit at Day 5 |
0.5; 2.6 | — |
| PRIMARY Local Tolerability Signs Total Composite Score by Visit at Day 8 |
0.5; 3.8 | — |
| PRIMARY Local Tolerability Signs Total Composite Score by Visit at Day 15 |
0.5; 1.6 | — |
| PRIMARY Local Tolerability Signs Total Composite Score by Visit at Day 29 |
0.5; 0.5 | — |
| PRIMARY Local Tolerability Signs Total Composite Score by Visit at Day 57 |
0.5; 0.1 | — |
| PRIMARY Maximum Local Tolerability Signs Total Composite Score Post Baseline |
0.5; 4.1 | — |
| PRIMARY Time to Maximum Local Tolerability Total Composite Score |
7.0 | — |
| PRIMARY Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5 |
22; 83; 22; 78; 28; 77 | — |
| PRIMARY Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8 |
22; 83; 21; 80; 28; 77 | — |
| PRIMARY Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15 |
22; 83; 21; 80; 28; 77 | — |
| PRIMARY Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29 |
22; 83; 20; 80; 28; 77 | — |
| PRIMARY Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57 |
22; 83; 18; 84; 28; 77 | — |
| PRIMARY Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) |
29; 2; 2 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters |
— | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
1 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Physical Examination |
1 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) |
1 | — |
Summary
The purpose of the study is to evaluate the safety, tolerability and treatment effect of tirbanibulin ointment 1% when applied to a field of approximately 100 cm^2 on the face or balding scalp.
Eligibility Criteria
Inclusion Criteria
- Having a treatment field (TF) on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that measures approximately 100 cm^2 (eg, mid face) and contains 4 to 12 clinically typical, visible, and discrete actinic keratosis (AK) lesions within the TF
- Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study
- Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provided written informed consent in accordance with institutional and regulatory guidelines
Exclusion Criteria
- Presence in the TF of
- Clinically atypical and/or rapidly changing AK lesions in the TF
- Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions) and/or cutaneous horn
- Confluent AK lesions (ie, non-discrete lesions defined as per inclusion criteria)
- History of invasive squamous cell carcinoma (SCC), Bowen's disease, basal cell carcinoma (BCC), or other malignant tumors in the TF
- Any other dermatological disease that causes difficulty with examination
- Previous treatment with tirbanibulin ointment 1%.
- Anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day 57
- Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the TF or within 2 cm of the TF, within 8 weeks prior to the Screening visit
- Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit
Data sourced from ClinicalTrials.gov (NCT05279131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.