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An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses (SK-FAN)

Aclaris Therapeutics logo

Aclaris Therapeutics

Status and phase

Completed
Phase 4

Conditions

Seborrheic Keratosis

Treatments

Drug: A-101 Topical Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT03487588
A-101-SEBK-402

Details and patient eligibility

About

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

Enrollment

41 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

41 participants in 1 patient group

A-101 Topical Solution
Experimental group
Description:
Open Label Arm
Treatment:
Drug: A-101 Topical Solution

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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