An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses

• A-101 Topical Solution (Drug): A-101 Topical Solution applied Day 1, Day 15 and Day 29

Primary outcomes

• Subject Satisfaction [Day 113]: Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution

Secondary outcomes

• Effectiveness of Treatment [Day 113]: Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness </= 1 mm); PLA=3 (Thick; thickness > 1 mm).
• Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction [Day 113]: Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion.

Sex: All, ages: 30 Years to 75 Years

Inclusion Criteria:

1. Subject can comprehend and is willing to sign an informed consent for participation in this study.
2. Male or female between the ages of 30 and 75 years old.
3. Subject has 3 eligible Seborrheic Keratoses; 2 target SKs must be on the face, and the additional 1 target SK must be on the neck or decolletage.
4. Subjects must have had cryosurgery for SK removal within the last 6 months and prior to first treatment with A-101 Topical Solution.
5. Target and non-target SKs must not have been previously treated.
6. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any target or non-target SK or which exposes the subject to an unacceptable risk by study participation

Exclusion Criteria:

1. Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.
2. Subject has current systemic malignancy.
3. Subject would require the use of any topical treatment (e.g., moisturizers, sunscreens) to any of the target or non-target SKs 12 hours prior to any study visit.
4. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations

Participant flow

Outcome results

• Subject Satisfaction (Primary), Count of participants, Participants: A-101 Topical Solution 21
• Effectiveness of Treatment (Secondary), Mean, score on a scale (PLA): A-101 Topical Solution -2.0 +/- 0.62
• Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction (Secondary), Number, point bi-serial correlation coefficient: A-101 Topical Solution .318

Adverse events

Time frame: 17 weeks; The reporting period for SAEs began when the subject signed the informed consent form. Non serious clinical AEs were collected following the application of the study drug at Visit 2 and continued through Visit 11. All safety reporting (AEs and SAEs) was concluded at Visit 11 (Day 113).

Other adverse events by term

• Study Protocol (PDF, 2018-06-18)
• Statistical Analysis Plan (PDF, 2018-12-13)

• David Gordon, MD, Study director, Aclaris Therapeutics