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CompletedNCT03487588SK-FANUpdated Oct 2, 2019Results posted

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

A Phase 4 interventional study of A-101 Topical Solution in Seborrheic Keratosis, sponsored by Aclaris Therapeutics, Inc.. Completed at 3 sites in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-02.

Sponsored by Aclaris Therapeutics, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
30 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

03

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    A-101 Topical Solution

    Open Label Arm

    Drug: A-101 Topical Solution

Interventions

  • DrugA-101 Topical Solution

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

05

What researchers measure

Primary outcomes

  1. Subject Satisfaction

    Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution

    Time frame: Day 113

Secondary outcomes

  1. 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 \</= 1 mm); PLA=3 (Thick; thickness \> 1 mm).

    Time frame: Day 113

  2. 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.

    Time frame: Day 113

06

Results

Posted Oct 2, 2019

Participant flow

Participant flow — Overall Study
MilestoneA-101 Topical Solution
Started41
Completed41
Not completed0

Outcome measures

PrimarySubject Satisfaction

Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution

Time frame:
Day 113
Reported as:
Count of participants · Participants
Subject Satisfaction
ParticipantsA-101 Topical Solution
very satisfied (5)21
satsified (4)14
moderately satisfied (3)4
slightly satisfied (2)0
not satisfied at all (1)2
SecondaryEffectiveness 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 \</= 1 mm); PLA=3 (Thick; thickness \> 1 mm).

Time frame:
Day 113
Reported as:
Mean · score on a scale (PLA)
Effectiveness of Treatment
score on a scale (PLA)A-101 Topical Solution
Effectiveness of Treatment-2.0 ± 0.62
SecondaryComparison 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.

Time frame:
Day 113
Reported as:
Number · point bi-serial correlation coefficient
Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction
point bi-serial correlation coefficientA-101 Topical Solution
Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction.318

Adverse events

Collected over 17 weeks; The reporting period for SAEs began when the subject signed the informed consent form. Non serious clinical AEs were collected following the application of the study drug at Visit 2 and continued through Visit 11. All safety reporting (AEs and SAEs) was concluded at Visit 11 (Day 113).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
A-101 Topical Solution0/41 (0%)0/41 (0%)8/41 (19.5%)
Most frequent other events
Most frequent other events
EventA-101 Topical Solution
Eyelid OedemaEye disorders2/41
Administration site discomfortGeneral disorders1/41
Administration site irritationGeneral disorders1/41
Arthropod stingInjury, poisoning and procedural complications1/41
FallInjury, poisoning and procedural complications1/41
Blood cholesterol increasedInvestigations1/41
Dermatitis contactSkin and subcutaneous tissue disorders1/41
Tooth extractionSurgical and medical procedures1/41

Baseline characteristics

Age, Continuous
Age, Continuous(years)A-101 Topical Solution
Mean62.4 ± 6.97
Sex: Female, Male
Sex: Female, Male(Participants)A-101 Topical Solution
Female24
Male17
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)A-101 Topical Solution
Hispanic or Latino0
Not Hispanic or Latino41
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)A-101 Topical Solution
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White41
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)A-101 Topical Solution
United States41
07

Study locations

3 sites
  • Aclaris Investigational Site
    Fort Washington, Pennsylvania 19034, United States
  • Aclaris Investigational Site
    Knoxville, Tennessee 37922, United States
  • Aclaris Investigational Site
    Austin, Texas 78759, United States
08

References and documents

Study documents

  • Study protocol · Jun 18, 2018
  • Statistical analysis plan · Dec 13, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03487588
Lead sponsor
Aclaris Therapeutics, Inc.
Responsible party
Sponsor
First posted
Apr 4, 2018
Start date
Mar 21, 2018
Primary completion
Nov 14, 2018
Completion
Nov 14, 2018
Results posted
Oct 2, 2019
Last update
Oct 2, 2019

Study contacts

David Gordon, MD
study director · Aclaris Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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