Seborrheic KeratosisPhase 2NCT02260180
Study 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 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 119 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2014to Mar 2015
- 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 to 75 years
- 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 Fitzpatrick skin type of 1-4
- Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
- Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face:
- Have a clinically typical appearance
- Be treatment naïve
Show all 22Show fewer
- Have a Physician's Lesion Assessment (PLA) of ≥2 (Section 6.1.2)
- Have a longest axis that is ≥7mm and ≤15mm (Section 5.4)
- Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm (Section 5.4)
- 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 on the eyelids
- Not be within 5mm of the orbital rim
- Not be covered with hair which, in the investigator's opinion, would interfere with the study medication application or the study evaluations (NB: the study medication may bleach hair)
- Not be in an intertriginous fold
- Not be pedunculated.
- If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control (Section 8) 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 the 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
Show all 22Show fewer
- Glucocortico-steroids; 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, which 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; 28 days
- Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
- Glucocortico-steroids or antibiotics; 14 days
- 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, which 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) which, in the investigator's opinion, 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
4 sites in 1 country.
United States4 sites
DermReseach, Inc.
Austin, Texas, 78759
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
Oregon Medical Research Center
Portland, Oregon, 97223
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 of the Face
The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.
Read the detailed description
The main objective of this study is to evaluate the dose-response relationship of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied to seborrheic Keratosis (SK) target lesions on the face. A further objective is to evaluate the safety and efficacy of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied topically up to 2 times to SK target lesions on the face.
- 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 |
|---|---|---|
| A-101 40% | Active comparator | A-101 40% Topical Solution Receives: Drug: A-101 |
| A-101 32.5% | Active comparator | A-101 32.5% Topical Solution Receives: Drug: A-101 |
| A-101 Vehicle Topical Solution | Placebo comparator | A-101 0% Topical Solution (vehicle) Receives: Drug: A-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8.
The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better.
Measured: Day 106
Secondary outcomes (1)
Mean Change From Baseline PLA Score at Visit 8
A secondary efficacy analysis was the mean change from baseline PLA Score at visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. A lower (more negative) mean change is a better outcome.
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 posted9 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Beger, BS, Study director, Aclaris Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260180
- Sponsor's protocol ID
- A-101-SEBK-203
- Status last verified
- Nov 2020
- First submitted
- 3 Oct 2014
- Last updated
- 2 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. 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 of the Face
- ClinicalTrials.gov ID
- NCT02260180
- Acronym / sponsor ID
- A-101-SEBK-203
- Conditions
- Seborrheic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Posted 6 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 purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.
Detailed description
The main objective of this study is to evaluate the dose-response relationship of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied to seborrheic Keratosis (SK) target lesions on the face. A further objective is to evaluate the safety and efficacy of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied topically up to 2 times to SK target lesions on the face.
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 40% | Active comparator | Drug: A-101A-101 40% Topical Solution |
| A-101 32.5% | Active comparator | Drug: A-101A-101 32.5% Topical Solution |
| A-101 Vehicle Topical Solution | Placebo comparator | Drug: A-101A-101 0% Topical Solution (vehicle) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Subject is at least 18 years of age
- Subject has a Fitzpatrick skin type of 1-4
- Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
- Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face:
- If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control (Section 8) for the duration of the study
Key exclusion criteria (22 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-101Topical Solution | Drug | A-101 32.5%, A-101 40%, A-101 Vehicle Topical Solution |
Primary outcome
Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8.
Time frame: Day 106
The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better.
1 secondary outcome
Mean Change From Baseline PLA Score at Visit 8
Time frame: Day 106
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Seborrheic Keratosis
RecruitingPhase 3
Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis
Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin
Not yet recruitingObservational study
AI in SK Histopathological Diagnosis
Seborrheic Keratoses, Artifical Intelligence
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.
Brian Beger, BS study director
Aclaris Therapeutics, Inc.
4 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 4 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 22 inclusion and 22 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm 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 2 Dec 2020.