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

Phase 4

Completed

• Conditions: Seborrheic Keratosis
• Interventions: Drug: A-101 Topical Solution

• Registration Number: NCT03487588
• Lead Sponsor: Aclaris Therapeutics, Inc.

Brief Summary

This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-02
• Study Start: 2018-03-21
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-04
• Primary Completion: 2018-11-14
• Study Completion: 2018-11-14
• Results First Submitted: 2019-09-12
• Results First Submitted QC: 2019-10-01
• Last Update Submitted: 2019-10-01
• Results First Posted: 2019-10-02
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A-101 Topical Solution	A-101 Topical Solution	Open Label Arm

Primary Outcome Measures

Name	Time	Method
Subject Satisfaction	Day 113	Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Aclaris Investigational Site; 🇺🇸 Austin, Texas, United States