Seborrheic KeratosisPhase 2NCT03148691
A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis
A Phase 2 study testing A-101 in people with Seborrheic Keratosis, run by Aclaris Therapeutics, Inc. at 9 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seborrheic Keratosis
- What is being tested?
- A-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 May 2017to 3 Apr 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to comprehend and is willing to sign an informed consent for participation in this study.
- Male or female ≥ 18 years old.
- Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis.
- Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face, with at least 1 Target Lesion on the face and at least 1 Target Lesion on the trunk or extremities. The 4 identified Target Lesions must meet the requirements as defined below:
- Have a clinically typical appearance
- Have a Physician's Lesion Assessment of ≥ 2
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- Length that is ≥ 5mm and ≤ 15mm
- Width that is ≥ 5mm and ≤ 15 mm
- Thickness that is ≤ 2mm
- Be a discrete lesion
- Be the only SK lesion present when centered in the area outlined by the provided circular template
- Not be covered with hair which, the in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
- Not be in the intertriginous fold
- Not be on the eyelids
- Not be within 5mm of the orbital rim
- Not be pedunculated
- Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
- Woman of childbearing potential must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
- Subject is non-pregnant and non-lactating.
- 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 Lesion or which exposes the subject to an unacceptable risk by study participation.
- Subject is willing and able to follow all study instructions and to attend all study visits.
Who cannot join
- Subject has clinically atypical and /or rapidly growing seborrheic keratosis lesions.
- Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser - Trelat).
- Subject has current systemic malignancy.
- Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
- Retinoids; 180 days
- Corticosteroids; 28 days
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- Anti-metabolites (e.g., methotrexate); 28 days
- Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, 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; 180 days
- Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-Fluorouracil, or ingenol mebutate; 60 days
- Hydrogen peroxide: 90 days
- Retinoids; 28 days
- Microdermabrasion or superficial chemical peels; 14 days
- Corticosteroids or antibiotics; 14 days
- Subject would require the use of any topical treatment (e.g. moisturizers, sunscreen) to any of the Target Lesions 12 hours prior to any study visit.
- Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:
- Cutaneous malignancy; 180 days
- Sunburn; currently
- Pre-malignancy (e.g. actinic keratosis); currently
- Body art (e.g. tattoos, piercing, etc.); currently
- Excessive tan; currently. The use of self-tanning lotions/sprays are prohibited.
- Subject has a history of sensitivity to any of the ingredients in the study medications.
- 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.
- Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
DermResearch Inc
Austin, Texas, 78759
Philadelphia Institute - Dermatology
Fort Washington, Pennsylvania, 19034
Greenville Dermatology
Greenville, South Carolina, 29607
The Skin Wellness Center, PC Clinical Research Division
Knoxville, Tennessee, 37922
Baumann Research Institute
Miami, Florida, 33137
Union Square Laser Dermatology
New York, New York, 10003
MedaPhase, Inc
Newnan, Georgia, 30263
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Effectiveness of A-101(Hydrogen Peroxide) Topical Solution in Subjects With Seborrheic Keratosis Lesions on the Trunk, Extremities, and Face
The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.
Read the detailed description
The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.
The secondary objectives of this study include duration of response of A-101. During the study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. For each subject, at least 1 SK Target Lesion must be on the face and at least 1 Target Lesion must be on the trunk or extremities. The Target Lesions will be treated at a maximum of two treatment visits.
- Conditions
- Seborrheic Keratosis
- Being tested
- A-101
- Medical subject headings
- Keratosis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-101Drug
Topical Solution
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle Topical Solution Receives: Drug: A-101 |
| A-101 Low Dose | Active comparator | A-101 Low Dose Topical Solution Receives: Drug: A-101 |
| A-101 High Dose | Active comparator | A-101 High DoseTopical Solution Receives: Drug: A-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8
Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8
Grade Descriptor
0 Clear: no visible seborrheic keratosis lesion
- Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated)
- Thin: a visible seborrheic keratosis lesion (thickness ≤ 1 mm)
- Thick: a visible seborrheic keratosis lesion (thickness > 1 mm)
Measured: Day 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start17 May 2017
- Primary completion28 Feb 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seborrheic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart D Shanler, MD, Study director, Aclaris Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148691
- Sponsor's protocol ID
- A-101-SEBK-204
- Status last verified
- May 2019
- First submitted
- 9 May 2017
- Last updated
- 6 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Effectiveness of A-101(Hydrogen Peroxide) Topical Solution in Subjects With Seborrheic Keratosis Lesions on the Trunk, Extremities, and Face
- ClinicalTrials.gov ID
- NCT03148691
- Acronym / sponsor ID
- A-101-SEBK-204
- Conditions
- Seborrheic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Posted 6 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.
Detailed description
The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.
The secondary objectives of this study include duration of response of A-101. During the study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. For each subject, at least 1 SK Target Lesion must be on the face and at least 1 Target Lesion must be on the trunk or extremities. The Target Lesions will be treated at a maximum of two treatment visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: A-101Vehicle Topical Solution |
| A-101 Low Dose | Active comparator | Drug: A-101A-101 Low Dose Topical Solution |
| A-101 High Dose | Active comparator | Drug: A-101A-101 High DoseTopical Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subject is able to comprehend and is willing to sign an informed consent for participation in this study.
- Male or female ≥ 18 years old.
- Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis.
- Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face, with at least 1 Target Lesion on the face and at least 1 Target Lesion on the trunk or extremities. The 4 identified Target Lesions must meet the requirements as defined below:
- Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
Key exclusion criteria (24 listed)
- Subject has clinically atypical and /or rapidly growing seborrheic keratosis lesions.
- Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser - Trelat).
- Subject has current systemic malignancy.
- Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
- Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-101Topical Solution | Drug | A-101 High Dose, A-101 Low Dose, Vehicle |
Primary outcome
Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8
Time frame: Day 106
Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8 Grade Descriptor 0 Clear: no visible seborrheic keratosis lesion 1. Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated) 2. Thin: a visible seborrheic keratosis lesion (thickness ≤ 1 mm) 3. Thick: a visible seborrheic keratosis lesion (thickness > 1 mm)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart D Shanler, MD study director
Aclaris Therapeutics, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A-101 in people with Seborrheic Keratosis, run by Aclaris Therapeutics, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8 (time frame: Day 106). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.