Overview

A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)

Status:
Completed
Trial end date:
2019-04-24
Target enrollment:
0
Participant gender:
All
Summary
This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Almirall, S.A.
Athenex, Inc.
Collaborator:
Athenex, Inc.
Treatments:
Tirbanibulin
Criteria
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, were in good general health.

4. Females were 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, were using highly effective contraception
for at least 30 days or 1 menstrual cycle, whichever was longer, prior to study
treatment and agreed 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 had not had a vasectomy, and whose partner was
reproductively capable, must had agreed to use barrier contraception from Screening
through 90 days after their last dose of study treatment.

6. All participants must had agreed 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 ultraviolet exposure.

8. Able to comprehend and were 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 centimeters (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 (e.g., 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 were 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 (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g.,
scarring, open wounds) that, in the opinion of the Investigator, might interfere with
the study conduct or evaluations, or which exposes the participant 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 were 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 was longer, before dosing.