CompletedPhase 4

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

United States41 participantsStarted 2018-03-21

Plain-language summary

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

Age range30 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Subject Satisfaction

Timeframe: Day 113

NCT IDNCT03487588

SponsorAclaris Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-14

Results submitted2019-09-12

Who can participate

Age range30 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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