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A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp (AK003)

Primary Purpose

Actinic Keratoses

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Placebo

KX2-391 Ointment 1%

About this trial

This is an interventional treatment trial for Actinic Keratoses focused on measuring Actinic Keratosis, Keratosis, Keratosis, Actinic, Skin Diseases, Actinic Keratoses, Precancerous Conditions, Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Males and females greater than or equal to (≥) 18 years old
A defined area on the face or scalp contains 4 to 8 clinically typical, visible, and discrete AK lesions
Participants who in the judgment of the Investigator, are in good general health
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.
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.
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
Willing to avoid excessive sun or UV exposure
Able to comprehend and are willing to sign the informed consent form (ICF).

Exclusion Criteria

Clinically atypical and/or rapidly changing AK lesions on the treatment area
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)
Been previously treated with KX2-391 Ointment
Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57
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
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
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)
Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit
A history of sensitivity and/or allergy to any of the ingredients in the study medication
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
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
Females who are pregnant or nursing
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

Sites / Locations

Coastal Clinical Research, Inc.
Advanced Research Associates
Center For Dermatology Clinical Research
Contour Dermatology
Western States Clincial Research, Inc.
Skin care Research, Inc
Olympian Clinical Research
Clinical Research of South Florida
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Arlington Dermatology
Deaconess Clinic Downtown
The Indiana Clinical Trials Center
DelRicht Research
ActivMed Practices & Research, Inc.
Minnesota Clinical Study Center
Skin Specialists PC
JDR Dermatology Research
Psoriasis Treatment Center of Central New Jersey
Academic Dermatology Associates
Mount Sinai Beth Israel
Skin Search of Rochester, Inc.
PMG Research of Cary
OnSite Clinical Solutions, LLC
PMG Research of Winston-Salem,LLC
CTI Clinical Research Center
Synexus US
J&S Studies, Inc.
Austin Institute for Clinical Research, Inc.
Center for Clinical Studies
Dermatology Research Center, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

KX2-391 Ointment 1%

Arm Description

Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp

KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

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.

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).

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03285477

First Posted

September 7, 2017

Last Updated

March 19, 2021

Sponsor

Almirall, S.A.

Collaborators

Athenex, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03285477

Brief Title

A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp

Acronym

AK003

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

September 18, 2017 (Actual)

Primary Completion Date

May 3, 2018 (Actual)

Study Completion Date

April 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Almirall, S.A.

Collaborators

Athenex, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

This study was a double-blinded, multicenter, activity, and safety study of KX2-391 Ointment administered topically to the face or scalp of participants with actinic keratosis. The study consists of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received 5 consecutive days of topical treatment, to be applied at the study site. Activity (lesion counts) and safety evaluations was performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratoses

Keywords

Actinic Keratosis, Keratosis, Keratosis, Actinic, Skin Diseases, Actinic Keratoses, Precancerous Conditions, Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

This study tested KX2-391 Ointment 1% against a placebo.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

All Central Vendors and the sponsor were masked. The sponsor was unblind at the end of Day 57.

Allocation

Randomized

Enrollment

351 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp

Arm Title

KX2-391 Ointment 1%

Arm Type

Experimental

Arm Description

KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Vehicle Ointment was used in participants with Clinically typical AK on the face or scalp.

Intervention Type

Drug

Intervention Name(s)

KX2-391 Ointment 1%

Intervention Description

The experimental drug, KX2-391 Ointment 1% was used in participants with Clinically typical AK on the face or scalp.

Primary Outcome Measure Information:

Title

Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions

Description

Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.

Time Frame

Day 57

Secondary Outcome Measure Information:

Title

Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57

Description

Time Frame

Day 57

Title

Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57

Description

Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp).

Time Frame

Days 8, 15, 29 and 57

Title

Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57

Description

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.

Time Frame

3, 6, 9 and 12 months post-Day 57

Title

Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)

Description

Time Frame

Day 57

Title

Number of Participants With Pigmentation and Scarring in the Treatment Area

Description

Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed.

Time Frame

Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57

Title

Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests

Description

Time Frame

Baseline (Day 1 predose) up to Day 57

Title

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

Description

Time Frame

From Day 57 up to 12-months post-Day 57

Title

Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis

Description

Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator.

Time Frame

From Baseline (Day 1 predose) up to Day 57

Title

Number of Participants With Clinically Significant Safety Observations- Vital Signs

Description

Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.

Time Frame

From Baseline (Day 1 predose) up to Day 57

Title

Number of Participants With Clinically Significant Safety Observations- Physical Examination

Description

A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.

Time Frame

From Baseline (Day 1 predose) up to Day 57

Title

Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs)

Description

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.

Time Frame

From Baseline (Day 1 predose) up to Day 57

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Males and females greater than or equal to (≥) 18 years old A defined area on the face or scalp contains 4 to 8 clinically typical, visible, and discrete AK lesions Participants who in the judgment of the Investigator, are in good general health 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. 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. 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 Willing to avoid excessive sun or UV exposure Able to comprehend and are willing to sign the informed consent form (ICF). Exclusion Criteria Clinically atypical and/or rapidly changing AK lesions on the treatment area 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) Been previously treated with KX2-391 Ointment Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57 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 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 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) Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit A history of sensitivity and/or allergy to any of the ingredients in the study medication 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 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 Females who are pregnant or nursing 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane Fang, MD

Organizational Affiliation

Athenex, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Coastal Clinical Research, Inc.

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Advanced Research Associates

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85308

Country

United States

Facility Name

Center For Dermatology Clinical Research

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Contour Dermatology

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

Western States Clincial Research, Inc.

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

Skin care Research, Inc

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Olympian Clinical Research

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Clinical Research of South Florida

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Arlington Dermatology

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Deaconess Clinic Downtown

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

The Indiana Clinical Trials Center

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

DelRicht Research

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

ActivMed Practices & Research, Inc.

City

Beverly

State/Province

Massachusetts

ZIP/Postal Code

01915

Country

United States

Facility Name

Minnesota Clinical Study Center

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Skin Specialists PC

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

JDR Dermatology Research

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Psoriasis Treatment Center of Central New Jersey

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Facility Name

Academic Dermatology Associates

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Mount Sinai Beth Israel

City

New York

State/Province

New York

ZIP/Postal Code

10013

Country

United States

Facility Name

Skin Search of Rochester, Inc.

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Facility Name

PMG Research of Cary

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27511

Country

United States

Facility Name

OnSite Clinical Solutions, LLC

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

PMG Research of Winston-Salem,LLC

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

CTI Clinical Research Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45212

Country

United States

Facility Name

Synexus US

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

J&S Studies, Inc.

City

College Station

State/Province

Texas

ZIP/Postal Code

77845

Country

United States

Facility Name

Austin Institute for Clinical Research, Inc.

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

Center for Clinical Studies

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Dermatology Research Center, Inc.

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84117

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33567191

Citation

Blauvelt A, Kempers S, Lain E, Schlesinger T, Tyring S, Forman S, Ablon G, Martin G, Wang H, Cutler DL, Fang J, Kwan MR; Phase 3 Tirbanibulin for Actinic Keratosis Group. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021 Feb 11;384(6):512-520. doi: 10.1056/NEJMoa2024040.

Results Reference

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A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp

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