Seborrheic KeratosisPhase 2NCT02160626
Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis
A Phase 2 study testing A-101 (40) Topical Solution and A-101 (32.5) Topical Solution in people with Seborrheic Keratosis, run by Aclaris Therapeutics, Inc. at 5 sites in United States.
Trial summary
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle. 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 (40) Topical Solution and A-101 (32.5) Topical Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2014to Dec 2014
- 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 at least 18 years of age
- Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
- Subject has 4 appropriate seborrheic keratosis target lesions, as defined below, on the trunk/extremities:
- Have a clinically typical appearance
- Be treatment naïve
- Have a Physician Lesion Assessment (PLA) of ≥2
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- Have a longest axis that is ≥7mm and ≤15mm
- Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm
- Have a thickness that is ≤2mm
- Be a discrete lesion
- Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present
- Not be in an intertriginous fold
- Not be in an area where clothing, such as a bra, might cause physical irritation
- Not be pedunculated.
- If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active form 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 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
- Subject is able to comprehend and willing to sign an Informed Consent Form (ICF).
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 a current systemic malignancy
- Subject has a history of keloid formation or hypertrophic scarring
- Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
- Retinoids; 180 days
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- Glucocorticosteroids; 28 days
- 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 the target lesion, that in the investigator's opinion, interferes with the application of the study medication or the study assessments:
- LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy; 180 days
- Retinoids; 90 days
- Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
- Glucocorticosteroids or antibiotics; 14 days
- Moisturizers/emollients, sunscreens; 12 hours
- Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to the target lesion that, in the investigator's opinion, interferes with the application of the study medication or the study assessments:
- A cutaneous malignancy; 180 days
- Experienced a sunburn; 28 days
- A pre-malignancy (e.g., actinic keratosis); currently
- Body art (e.g., tattoos, piercing, etc.); currently
- Excessive tan; currently
- 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, 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
- Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
DermReseach, Inc.
Austin, Texas, 78759
Michigan Center for Research Corp.
Clinton Township, Michigan, 48038
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
Oregon Medical Research Center
Portland, Oregon, 97223
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078
About this study
Official title: A Randomized, Double-Blind, Vehicle Controlled, Parallel Group Study of the Dose-Response Profile of A-101 Topical Solution in Subjects With Seborrheic Keratosis.
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.
Read the detailed description
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.
Each subject will have 4 target lesions on the trunk/extremities.
A further objective is to evaluate the safety and efficacy of two concentrations of A-101 solution and its matching vehicle when applied to SK target lesions on the trunk/extremities.
- Conditions
- Seborrheic Keratosis
- Being tested
- A-101 Vehicle, A-101 (40) Topical Solution, A-101 (32.5) Topical Solution
- Keywords
- Seborrheic keratosis, A101
- 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-101 VehicleDrug
Placebo control
A-101 (40) Topical SolutionDrug
A-101 (40) Topical Solution - high dose
A-101 (32.5) Topical SolutionDrug
A-101 (32.5) Topical Solution - low dose
| Study group | Role | What they receive |
|---|---|---|
| A-101 Vehicle | Placebo comparator | A-101 Vehicle (placebo) Topical Solution Receives: Drug: A-101 Vehicle |
| A-101 (40) Topical Solution | Active comparator | A-101 (40) Topical Solution - high dose Receives: Drug: A-101 (40) Topical Solution |
| A-101 (32.5) Topical Solution | Active comparator | A-101 (32.5) Topical Solution - low dose Receives: Drug: A-101 (32.5) Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA)
Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.
Measured: Baseline, visit 8
Secondary outcomes (2)
Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment
Change from baseline PLA will be calculated for each lesion first, then per-subject mean changes from baseline will be calculated.
The PLA is a score on a four scale from 0 to 3 with 0 being clear and 3 being the most severe, a lower score indicating a better result. For the mean change in this score, a larger mean change is a better result.
Measured: Baseline, visit 8
Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8.
Proportion of Subjects who had at least 3 of 4 target lesions judged to be clear on the Physician Lesion Assessment (PLA =0) at visit 8. The PLA is a 4 point scale evaluating the severity of a lesion with 0 being clear and 3 being the most severe.
Measured: Baseline, visit 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan S Weiss, MD, Principal investigator, Gwinnett Clinical Research Center, Inc.Janet Dubois, MD, Principal investigator, Derm Research, PLLCDavid C Wilson, MD, Principal investigator, The Education & Research Foundation, Inc.Daniel M Stewart, DO, Principal investigator, Michigan Center for Research Corp.Andrew Blauvelt, MD, MBA, Principal investigator, Oregon Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160626
- Sponsor's protocol ID
- A-101-SEBK-202
- Status last verified
- Dec 2018
- First submitted
- 6 Jun 2014
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle Controlled, Parallel Group Study of the Dose-Response Profile of A-101 Topical Solution in Subjects With Seborrheic Keratosis.
- ClinicalTrials.gov ID
- NCT02160626
- Acronym / sponsor ID
- A-101-SEBK-202
- Conditions
- Seborrheic Keratosis
- Keywords
- Seborrheic keratosis, A101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Posted 7 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.
Detailed description
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.
Each subject will have 4 target lesions on the trunk/extremities.
A further objective is to evaluate the safety and efficacy of two concentrations of A-101 solution and its matching vehicle when applied to SK target lesions on the trunk/extremities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A-101 Vehicle | Placebo comparator | Drug: A-101 VehicleA-101 Vehicle (placebo) Topical Solution |
| A-101 (40) Topical Solution | Active comparator | Drug: A-101 (40) Topical SolutionA-101 (40) Topical Solution - high dose |
| A-101 (32.5) Topical Solution | Active comparator | Drug: A-101 (32.5) Topical SolutionA-101 (32.5) Topical Solution - low dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subject is at least 18 years of age
- Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
- Subject has 4 appropriate seborrheic keratosis target lesions, as defined below, on the trunk/extremities:
- If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active form of birth control for the duration of the study
- Subject is non-pregnant and non-lactating
Key exclusion criteria (23 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 a current systemic malignancy
- Subject has a history of keloid formation or hypertrophic scarring
- Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
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-101 VehiclePlacebo control | Drug | A-101 Vehicle |
| A-101 (40) Topical SolutionA-101 (40) Topical Solution - high dose | Drug | A-101 (40) Topical Solution |
| A-101 (32.5) Topical SolutionA-101 (32.5) Topical Solution - low dose | Drug | A-101 (32.5) Topical Solution |
Primary outcome
Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA)
Time frame: Baseline, visit 8
Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.
2 secondary outcomes
Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment
Time frame: Baseline, visit 8
Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8.
Time frame: Baseline, visit 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jonathan S Weiss, MD principal investigator
Gwinnett Clinical Research Center, Inc.
Janet Dubois, MD principal investigator
Derm Research, PLLC
David C Wilson, MD principal investigator
The Education & Research Foundation, Inc.
5 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 (40) Topical Solution and A-101 (32.5) Topical Solution in people with Seborrheic Keratosis, run by Aclaris Therapeutics, Inc. at 5 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 19 inclusion and 23 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 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 7 Dec 2018). 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 Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA) (time frame: Baseline, visit 8). 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 3 Jan 2019.