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

Seborrheic Keratosis Clinical Trial

— SK-FAN  

Official title:

An Open-Label Study Assessing Subject Satisfaction With A-101 Hydrogen Peroxide Topical Solution, 40% (w/w) Treatment for Seborrheic Keratoses of the Face, Neck, and Decolletage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487588
• Other study ID #: A-101-SEBK-402
• Status: Completed
• Phase: Phase 4
• Start date: March 21, 2018
• Est. completion date: November 14, 2018

Study information

• Verified date: March 2018
• Source: Aclaris Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 14, 2018
• Est. primary completion date: November 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic
• Keratosis, Seborrheic
• Seborrheic Keratosis

Intervention

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

Locations

Country	Name	City	State
United States	Aclaris Investigational Site	Austin	Texas
United States	Aclaris Investigational Site	Fort Washington	Pennsylvania
United States	Aclaris Investigational Site	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Aclaris Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject Satisfaction	Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution	Day 113
Secondary	Effectiveness of Treatment	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	Day 113
Secondary	Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction	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.	Day 113