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CompletedNCT02667236Updated Feb 6, 2018Results posted

A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis.

A Phase 3 interventional study of A-101 Solution and Vehicle Solution in Seborrheic Keratosis, sponsored by Aclaris Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-06.

Sponsored by Aclaris Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101 Solution 40% compared with Vehicle Solution.

Read the detailed description

This is a randomized, double-blind, vehicle-controlled, parallel group study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. The Target Lesions will be treated, by an investigational staff member other than the evaluating investigator, a maximum of two times.

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Conditions studied

  • Seborrheic Keratosis

Keywords

  • seborrheic keratosis
03

In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 450 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Aclaris Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 22 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject is at least 18 years of age
  2. Clinical diagnosis of stable clinically typical seborrheic keratosis
  3. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face that each are eligible for treatment as defined below:

    • Have a clinically typical appearance
    • Have a PLA of 2 or greater and be a discrete lesion
    • Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
    • Not be in an intertriginous fold
    • Not be on the eyelids
    • Not be within 5mm of the orbital rim
    • Not be pedunculated
  4. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active method of birth control for the duration of the study
  5. Subject is non-pregnant and non-lactating
  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 evaluation of any Target Lesion or which exposes the subject to an unacceptable risk by study participation
  7. Subject is willing and able to follow all study instructions and to attend all study visits
  8. Subject is able to comprehend and willing to sign an Informed Consent Form.

Exclusion criteria

Exclusion Criteria:

  1. Subject has clinically atypical and - or rapidly growing seborrheic keratosis lesions
  2. Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser -Trelat)
  3. Subject has a current systemic malignancy
  4. Subject has used any of the following systemic therapies within the specified period prior to enrollment:

    • Retinoids; 180 days
    • Glucocortico-steroids;
    • Anti-metabolites (e.g., methotrexate);
  5. Subject has used any of the following topical therapies within the specified period or in a proximity to any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments:

    • LASER, light or other energy based therapy (e.g., intense pulsed light, photo-dynamic therapy;
    • Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol mebutate;
    • Retinoids;
    • Microdermabrasion or superficial chemical peels;
    • Glucocortico-steroids or antibiotics
  6. Subject currently has or has had any of the following within the specified period or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:

    • A cutaneous malignancy;
    • A sunburn; currently
    • A pre-malignancy (e.g., actinic keratosis); currently
    • Body art (e.g., tattoos, piercing, etc.); currently
    • Excessive tan; currently
  7. Subject has a history of sensitivity to any of the ingredients in the study medications
  8. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), 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
  9. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
450 participants (actual)

Study arms

  • Active comparator
    A-101 Solution

    A-101 Solution 40% administered once

    Drug: A-101 Solution

  • Placebo comparator
    Vehicle Solution

    Vehicle Solution administered once

    Other: Vehicle Solution

Interventions

  • DrugA-101 Solution

    Active Drug

  • OtherVehicle Solution

    Placebo

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What researchers measure

Primary outcomes

  1. Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment

    Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.

    Time frame: Day 106 of the study

Secondary outcomes

  1. Proportion of Subjects With 3 of 4 Target Lesion Clearance

    Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8

    Time frame: Day 106 of the study

07

Results

Posted Nov 13, 2017

Participant flow

Participant flow — Overall Study
MilestoneA-101 SolutionVehicle Solution
Started223227
Completed220226
Not completed31
Withdrew: Adverse event11
Withdrew: Withdrawal by subject20

Outcome measures

PrimaryProportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment

Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.

Time frame:
Day 106 of the study
Reported as:
Count of participants · Participants
Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment
ParticipantsA-101 SolutionVehicle Solution
Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment90
SecondaryProportion of Subjects With 3 of 4 Target Lesion Clearance

Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8

Time frame:
Day 106 of the study
Reported as:
Count of participants · Participants
Proportion of Subjects With 3 of 4 Target Lesion Clearance
ParticipantsA-101 SolutionVehicle Solution
Proportion of Subjects With 3 of 4 Target Lesion Clearance300

Adverse events

Collected over Adverse events were collected from V2 (Day 1) through V8 (Day 106). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
A-101 Solution0/223 (0%)4/223 (1.8%)10/223 (4.5%)
Vehicle Solution0/227 (0%)6/227 (2.6%)14/227 (6.2%)
Most frequent serious events
Most frequent serious events
EventA-101 SolutionVehicle Solution
OsteoarthritisMusculoskeletal and connective tissue disorders0/2232/227
Intervertebral disc disorderMusculoskeletal and connective tissue disorders1/2230/227
Rotator cuff syndromeMusculoskeletal and connective tissue disorders1/2230/227
Central nervous system lesionNervous system disorders1/2230/227
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders1/2230/227
Acute myocardial infarctionCardiac disorders0/2231/227
Gastric UlcerGastrointestinal disorders0/2231/227
Ischaemic strokeNervous system disorders0/2231/227
Mental Status ChangesPsychiatric disorders0/2231/227
HypertensionVascular disorders0/2231/227
Most frequent other events
Most frequent other events
EventA-101 SolutionVehicle Solution
NasopharyngitisInfections and infestations3/2237/227
Seasonal AllergyImmune system disorders0/2234/227
BronchitisInfections and infestations3/2231/227
Actinic KeratosisSkin and subcutaneous tissue disorders3/2230/227
Upper Respiratory InfectionInfections and infestations1/2233/227

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)A-101 SolutionVehicle SolutionTotal
<=18 years000
Between 18 and 65 years7255127
>=65 years151172323
Age, Continuous
Age, Continuous(years)A-101 SolutionVehicle SolutionTotal
Mean68.3 ± 8.4269.1 ± 8.7168.7 ± 8.57
Sex: Female, Male
Sex: Female, Male(Participants)A-101 SolutionVehicle SolutionTotal
Female138126264
Male85101186
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)A-101 SolutionVehicle SolutionTotal
Hispanic or Latino5510
Not Hispanic or Latino214216430
Unknown or Not Reported4610
Race (NIH/OMB)
Race (NIH/OMB)(Participants)A-101 SolutionVehicle SolutionTotal
American Indian or Alaska Native000
Asian246
Native Hawaiian or Other Pacific Islander000
Black or African American112
White219221440
More than one race000
Unknown or Not Reported112
Region of Enrollment
Region of Enrollment(participants)A-101 SolutionVehicle SolutionTotal
United States223227450
08

Study locations

1 site
  • Aclaris Therapeutics, Inc.
    Malvern, Pennsylvania 19355, United States
09

References and documents

Publications

  • Smith SR, Xu S, Estes E, Shanler SD. Anatomic Site-Specific Treatment Response With 40% Hydrogen Peroxide (w/w) Topical Formulation for Raised Seborrheic Keratoses: Pooled Analysis of Data from Two Phase 3 Studies. J Drugs Dermatol. 2018 Oct 1;17(10):1092-1098. PubMed 30365590 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02667236
Lead sponsor
Aclaris Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jan 28, 2016
Start date
Jan 2016
Primary completion
Oct 2016
Completion
Oct 2016
Results posted
Nov 13, 2017
Last update
Feb 6, 2018

Study contacts

Stuart D Shanler, MD
study director · Chief SCience Officer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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