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Completed

NCT Number: NCT03487588

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

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

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aclaris Investigational Site, Fort Washington, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject can comprehend and is willing to sign an informed consent for participation in this study.
  • Male or female between the ages of 30 and 75 years old.
  • 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.
  • Subjects must have had cryosurgery for SK removal within the last 6 months and prior to first treatment with A-101 Topical Solution.
  • Target and non-target SKs must not have been previously treated.
  • 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

  • Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.
  • Subject has current systemic malignancy.
  • 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.
  • 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

Treatment and study plan

A-101 Topical Solution

Drug

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

Primary outcomes

  1. Subject Satisfaction

    Time frame: Day 113

    Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution

Secondary outcomes

  1. Effectiveness of Treatment

    Time frame: 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).

  2. Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aclaris Therapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: SK-FAN

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2018
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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