Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp

Completed · Phase 2

Conditions studied: Actinic Keratosis

In brief

In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.

Key facts

Study ID

NCT02838628

Run by

Almirall, S.A.

People needed

168

Starts

2016-04-11

Expected to finish

2017-12-22

Last updated by the study team

2021-04-14

Who can join

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

You may qualify if…

• Males and females ≥18 years old
• Clinical diagnosis of stable, clinically typical actinic keratosis
• A define treatment area on the face or scalp
• Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with KX2-391 Ointment
• Males who have not had a vasectomy must agree to use barrier contraception
• Participants who in the judgment of the Investigator, are in good general health
• Willing to avoid excessive sun exposure
• Able to comprehend and are willing to sign an informed consent form (ICF)

You may not qualify if…

• Clinically atypical and/or rapidly changing AK lesions on the treatment area
• Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence
• Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1
• Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
• Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
• A history of sensitivity and/or allergy to any of the ingredients in the study medication
• A skin disease or condition that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an 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 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing.

Where it is running

• Center for Dermatology Clinical Research — Fremont, California, United States
• eStudy Site — La Mesa, California, United States
• Palmtree Clinical Research, Inc. — Palm Springs, California, United States
• Horizons Clinical Research Center — Denver, Colorado, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• International Dermatology Research — Miami, Florida, United States
• Compass Research — Orlando, Florida, United States
• Forward Clinical Trials, Inc. — Tampa, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Dermatology and Laser Center of Charleston — Charleston, South Carolina, United States
• Institute of Clinical Research - Tennessee, LLC — Murfreesboro, Tennessee, United States
• J&S Studies, Inc. — College Station, Texas, United States
• The Center for Skin Research — Houston, Texas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• Dermatology Clinical Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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