Actinic Keratoses Clinical Trial
— AK003Official title:
A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp
Verified date | March 2021 |
Source | Almirall, S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase III study is designed to evaluate the efficacy and safety of KX2-391 Ointment in adult participants when applied to an area of skin containing 4-8 stable, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.
Status | Completed |
Enrollment | 351 |
Est. completion date | April 24, 2019 |
Est. primary completion date | May 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria 1. Males and females greater than or equal to (=) 18 years old 2. A defined area on the face or scalp contains 4 to 8 clinically typical, visible, and discrete AK lesions 3. Participants who in the judgment of the Investigator, are in good general health 4. Females must be postmenopausal [greater than (>) 45 years of age with at least 12 months of amenorrhea], surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of childbearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device or complete abstinence from sexual intercourse. 5. Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment. 6. All participants must agree not to donate sperm or eggs or attempt conception from Screening through 90 days following their last dose of study treatment 7. Willing to avoid excessive sun or UV exposure 8. Able to comprehend and are willing to sign the informed consent form (ICF). Exclusion Criteria 1. Clinically atypical and/or rapidly changing AK lesions on the treatment area 2. Location of the selected area is: - On any location other than the face or scalp - Within 5 cm of an incompletely healed wound - Within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) 3. Been previously treated with KX2-391 Ointment 4. Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57 5. Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening visit 6. Use of the following therapies and/or medications within 2 weeks prior to the Screening visit: - Cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area - Acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area - Topical salves (non-medicated/non-irritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area 7. Use of the following therapies and/or medications within 4 weeks prior to the Screening visit: - Treatment with immunomodulators (eg, azathioprine), cytotoxic drugs (eg, cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon inducers - Treatment with systemic medications that suppress the immune system (eg, cyclosporine, prednisone, methotrexate, alefacept, infliximab) 8. Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit 9. A history of sensitivity and/or allergy to any of the ingredients in the study medication 10. A skin disease (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participants to unacceptable risk by study participation 11. Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation 12. Females who are pregnant or nursing 13. Participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing |
Country | Name | City | State |
---|---|---|---|
United States | Academic Dermatology Associates | Albuquerque | New Mexico |
United States | Arlington Dermatology | Arlington Heights | Illinois |
United States | ActivMed Practices & Research, Inc. | Beverly | Massachusetts |
United States | Skin care Research, Inc | Boca Raton | Florida |
United States | PMG Research of Cary | Cary | North Carolina |
United States | OnSite Clinical Solutions, LLC | Charlotte | North Carolina |
United States | CTI Clinical Research Center | Cincinnati | Ohio |
United States | Olympian Clinical Research | Clearwater | Florida |
United States | J&S Studies, Inc. | College Station | Texas |
United States | Clinical Research of South Florida | Coral Gables | Florida |
United States | Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey |
United States | Deaconess Clinic Downtown | Evansville | Indiana |
United States | Center For Dermatology Clinical Research | Fremont | California |
United States | Minnesota Clinical Study Center | Fridley | Minnesota |
United States | Advanced Research Associates | Glendale | Arizona |
United States | Synexus US | Greer | South Carolina |
United States | JDR Dermatology Research | Las Vegas | Nevada |
United States | Coastal Clinical Research, Inc. | Mobile | Alabama |
United States | DelRicht Research | New Orleans | Louisiana |
United States | Mount Sinai Beth Israel | New York | New York |
United States | Skin Specialists PC | Omaha | Nebraska |
United States | Leavitt Medical Associates of Florida d/b/a Ameriderm Research | Ormond Beach | Florida |
United States | Austin Institute for Clinical Research, Inc. | Pflugerville | Texas |
United States | The Indiana Clinical Trials Center | Plainfield | Indiana |
United States | Contour Dermatology | Rancho Mirage | California |
United States | Skin Search of Rochester, Inc. | Rochester | New York |
United States | Dermatology Research Center, Inc. | Salt Lake City | Utah |
United States | Center for Clinical Studies | Webster | Texas |
United States | Western States Clincial Research, Inc. | Wheat Ridge | Colorado |
United States | PMG Research of Winston-Salem,LLC | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Almirall, S.A. | Athenex, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions | Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area. | Day 57 | |
Secondary | Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57 | Partial clearance rate of AK lesions was defined as the percentage of participants with a greater than or equal to (>=) 75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the treatment area. | Day 57 | |
Secondary | Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 | Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp). | Days 8, 15, 29 and 57 | |
Secondary | Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57 | Recurrence rate was estimated based on Kaplan-Meier method, with recurrence define as appearance of any AK lesions in the treatment area, including those recurred or newly identified. | 3, 6, 9 and 12 months post-Day 57 | |
Secondary | Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR) | Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. The LSR assessment was an Investigator's (or sub-investigator's) assessment of the following signs on the treatment area: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. The LSRs were graded on a 4-point scale ranging from 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). | Day 57 | |
Secondary | Number of Participants With Pigmentation and Scarring in the Treatment Area | Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed. | Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57 | |
Secondary | Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests | An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. TEAEs (serious and non-serious) were defined as either those AEs with onset after first dose or those pre-existing AEs that worsen after first dose. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy. | Baseline (Day 1 predose) up to Day 57 | |
Secondary | Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57 | An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy. | From Day 57 up to 12-months post-Day 57 | |
Secondary | Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis | Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator. | From Baseline (Day 1 predose) up to Day 57 | |
Secondary | Number of Participants With Clinically Significant Safety Observations- Vital Signs | Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator. | From Baseline (Day 1 predose) up to Day 57 | |
Secondary | Number of Participants With Clinically Significant Safety Observations- Physical Examination | A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator. | From Baseline (Day 1 predose) up to Day 57 | |
Secondary | Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs) | ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator. | From Baseline (Day 1 predose) up to Day 57 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03575780 -
Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis
|
Phase 1 | |
Completed |
NCT04085367 -
Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
|
Phase 3 | |
Completed |
NCT05937529 -
Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis
|
N/A | |
Completed |
NCT02520700 -
A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses
|
N/A | |
Terminated |
NCT01538901 -
Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients
|
Phase 4 | |
Completed |
NCT01354717 -
Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo
|
Phase 3 | |
Completed |
NCT00742391 -
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
|
Phase 3 | |
Suspended |
NCT03963102 -
Duration of Ameluz Application in Acral Actinic Keratoses Response
|
Phase 4 | |
Not yet recruiting |
NCT05923060 -
Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses
|
Phase 2 | |
Withdrawn |
NCT06026358 -
Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands
|
Phase 4 | |
Completed |
NCT02622594 -
Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times
|
Phase 4 | |
Completed |
NCT00786994 -
The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
|
Phase 2 | |
Completed |
NCT00774787 -
Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
|
Phase 4 | |
Completed |
NCT00544258 -
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
|
Phase 1 | |
Completed |
NCT04024579 -
Treatment of Actinic Keratosis With 5% KOH Solution
|
||
Completed |
NCT04843553 -
Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients
|
Early Phase 1 | |
Completed |
NCT03315286 -
Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
|
N/A | |
Completed |
NCT03279328 -
Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents
|
Phase 4 | |
Completed |
NCT02062853 -
Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video
|
N/A | |
Terminated |
NCT01532453 -
Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients
|
Phase 3 |