Seborrheic KeratosisPhase 3SKNCT02667275
A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis
A Phase 3 study testing A-101 Solution in people with Seborrheic Keratosis, run by Aclaris Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a randomized, double-blind, vehicle-controlled, parallel group study. 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 Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 487 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Oct 2016
- Phase
- Phase 3
- 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
- Clinical diagnosis of stable clinically typical seborrheic keratosis
- 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
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- Not be in an intertriginous fold
- Not be on the eyelids
- Not be within 5mm of the orbital rim
- 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 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 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Aclaris Therapeutics, Inc.
Malvern, Pennsylvania, 19355
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, PArallel Group Study of the Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.
This is a randomized, double-blind, vehicle-controlled, parallel group study.
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.
- Conditions
- Seborrheic Keratosis
- Being tested
- A-101 Solution, Vehicle Solution
- Keywords
- seborrheic keratosis
- 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 SolutionDrug
Vehicle SolutionOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A-101 Solution | Experimental | A-101 Solution 40% administered once Receives: Drug: A-101 Solution |
| Vehicle Solution | Placebo comparator | Vehicle Solution administered once Receives: Other: Vehicle Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale
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 Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.
Measured: Study day 106
Secondary outcomes (1)
Percent of Lesions Cleared Scale
Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8
Measured: Study day 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionOct 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 487 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
- NCT02667275
- Sponsor's protocol ID
- A-101-SEBK-302
- Acronym
- SK
- Status last verified
- Jan 2016
- First submitted
- 26 Jan 2016
- Last updated
- 6 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. 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 Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.
- ClinicalTrials.gov ID
- NCT02667275
- Acronym / sponsor ID
- SK / A-101-SEBK-302
- Conditions
- Seborrheic Keratosis
- Keywords
- seborrheic keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Posted 13 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, vehicle-controlled, parallel group study.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-101 Solution | Experimental | Drug: A-101 SolutionA-101 Solution 40% administered once |
| Vehicle Solution | Placebo comparator | Other: Vehicle SolutionVehicle Solution administered once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject is at least 18 years of age
- Clinical diagnosis of stable clinically typical seborrheic keratosis
- Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face that each are eligible for treatment as defined below:
- 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
- Subject is non-pregnant and non-lactating
Key exclusion criteria (14 listed)
- 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;
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 Solution | Drug | A-101 Solution |
| Vehicle SolutionPlacebo | Other | Vehicle Solution |
Primary outcome
Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale
Time frame: Study day 106
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 Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.
1 secondary outcome
Percent of Lesions Cleared Scale
Time frame: Study day 106
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30365590Smith 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A-101 Solution in people with Seborrheic Keratosis, run by Aclaris Therapeutics, Inc. at 1 site 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 15 inclusion and 14 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 Nov 2017). 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?
Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale (time frame: Study day 106). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02667275, which also lists 1 linked publication.
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 Feb 2018.