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

Completed · Phase 3 · Has a placebo group

Conditions studied: Actinic Keratoses

In brief

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.

Key facts

Study ID: NCT03285477
Run by: Almirall, S.A.
People needed: 351
Starts: 2017-09-18
Expected to finish: 2019-04-24
Last updated by the study team: 2021-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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

Where it is running

Coastal Clinical Research, Inc. — Mobile, Alabama, United States
Advanced Research Associates — Glendale, Arizona, United States
Center For Dermatology Clinical Research — Fremont, California, United States
Contour Dermatology — Rancho Mirage, California, United States
Western States Clincial Research, Inc. — Wheat Ridge, Colorado, United States
Skin care Research, Inc — Boca Raton, Florida, United States
Olympian Clinical Research — Clearwater, Florida, United States
Clinical Research of South Florida — Coral Gables, Florida, United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research — Ormond Beach, Florida, United States
Arlington Dermatology — Arlington Heights, Illinois, United States
Deaconess Clinic Downtown — Evansville, Indiana, United States
The Indiana Clinical Trials Center — Plainfield, Indiana, United States
DelRicht Research — New Orleans, Louisiana, United States
ActivMed Practices & Research, Inc. — Beverly, Massachusetts, United States
Minnesota Clinical Study Center — Fridley, Minnesota, United States
Skin Specialists PC — Omaha, Nebraska, United States
JDR Dermatology Research — Las Vegas, Nevada, United States
Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States
Academic Dermatology Associates — Albuquerque, New Mexico, United States
Mount Sinai Beth Israel — New York, New York, United States
Skin Search of Rochester, Inc. — Rochester, New York, United States
PMG Research of Cary — Cary, North Carolina, United States
OnSite Clinical Solutions, LLC — Charlotte, North Carolina, United States
PMG Research of Winston-Salem,LLC — Winston-Salem, North Carolina, United States
CTI Clinical Research Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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