Clinical trial NCT05279131: A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis
Official title: A Phase 3, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% Applied to a Field of Approximately 100 cm2 on the Face or Balding Scalp in Adult Patients With Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratosis, Actinic
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2022-03-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

  1. Clinically atypical and/or rapidly changing AK lesions in the TF
  2. Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions) and/or cutaneous horn
  3. Confluent AK lesions (ie, non-discrete lesions defined as per inclusion criteria)
  4. History of invasive squamous cell carcinoma (SCC), Bowen's disease, basal cell carcinoma (BCC), or other malignant tumors in the TF
  5. 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Day 5
measure: 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
timeFrame: Baseline, Day 8
measure: 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
timeFrame: Baseline, Day 15
measure: 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
timeFrame: Baseline, Day 29
measure: 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
timeFrame: Baseline, Day 57
measure: Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration)
timeFrame: Baseline, Maximum post-baseline (up to Day 57)
measure: Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration
timeFrame: Baseline up to Day 57
measure: Local Tolerability Signs Total Composite Score by Visit at Day 5
timeFrame: Baseline, Day 5
measure: Local Tolerability Signs Total Composite Score by Visit at Day 8
timeFrame: Baseline, Day 8
measure: Local Tolerability Signs Total Composite Score by Visit at Day 15
timeFrame: Baseline, Day 15
measure: Local Tolerability Signs Total Composite Score by Visit at Day 29
timeFrame: Baseline, Day 29
measure: Local Tolerability Signs Total Composite Score by Visit at Day 57
timeFrame: Baseline, Day 57
measure: Maximum Local Tolerability Signs Total Composite Score Post Baseline
timeFrame: Baseline, Maximum post-baseline (up to Day 57)
measure: Time to Maximum Local Tolerability Total Composite Score
timeFrame: Baseline up to Day 57
measure: Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5
timeFrame: Baseline, Day 5
measure: Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8
timeFrame: Baseline, Day 8
measure: Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15
timeFrame: Baseline, Day 15
measure: Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29
timeFrame: Baseline, Day 29
measure: Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57
timeFrame: Baseline, Day 57
measure: Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to Day 57
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
timeFrame: Baseline up to Day 57
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Baseline up to Day 57
measure: Number of Participants With Clinically Significant Abnormalities in Physical Examination
timeFrame: Baseline up to Day 57
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
timeFrame: Baseline up to Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Almirall Investigation Site 7
state: Arkansas
city: Encinitas
country: United States
facility: Almirall Investigation Site 6
state: California
city: Sweetwater
country: United States
facility: Almirall Investigation Site 3
state: Florida
city: Rolling Meadows
country: United States
facility: Almirall Investigation Site 5
state: Illinois
city: Austin
country: United States
facility: Almirall Investigation Site 4
state: Texas
city: College Station
country: United States
facility: Almirall Investigational Site 1
state: Texas
city: San Antonio
country: United States
facility: Almirall Investigation Site 2
state: Texas
Study officials:
References: