Seborrheic Keratosis (SK)Phase 1/2NCT01986920
Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis
A Phase 1/2 study testing A-101 25%, A-101 32.5% and A-101 40% in people with Seborrheic Keratosis (SK), run by Aclaris Therapeutics, Inc. at 1 site in United States.
Trial summary
Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seborrheic Keratosis (SK)
- What is being tested?
- A-101 25%, A-101 32.5% and A-101 40%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2013to 25 Feb 2014
- Phase
- Phase 1/2
- 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
- Is at least 18 years of age
- Has a clinical diagnosis of stable clinically typical seborrheic keratosis
- Has at least 4 appropriate seborrheic keratosis target lesions on the back
- If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study
- Is non-pregnant and non-lactating
- Is in good general health and free of any 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
- Is willing and able to follow all study instructions and to attend all study visits
- Is able to comprehend and willing to sign an Informed Consent Form (ICF).
Who cannot join
- Has clinically atypical and/or rapidly growing seborrheic keratosis lesions
- Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
- Has used any of the following systemic therapies within the specified period prior to Visit 1:
- Retinoids; 180 days
- Glucocorticosteroids; 28 days
- Anti-metabolites (e.g., methotrexate); 28 days
Show all 22Show fewer
- Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1:
- 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
- Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days prior to Visit 1
- Has a history of keloid formation or hypertrophic scarring
- Has a current systemic malignancy
- Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area
- Has a current pre-malignancy (e.g., actinic keratosis) on the treatment area
- Has had body art (e.g., tattoos, piercing, sculpting, etc.) or any other invasive, non-therapeutic procedure performed on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
- Has excessive tan on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
- Has experienced a sunburn on the treatment area within the previous 4 weeks
- Has a history of sensitivity to any of the ingredients in the study medications
- Has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, tattoos, excessive hair, open wounds on the back) that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
- 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
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Within-Subject, Comparison Study of the Safety, Tolerability, And Effectiveness of A-101 Topical Solution in Subjects With Seborrheic Keratosis
Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.
Read the detailed description
The main objective of this study is to evaluate the safety, effectiveness and tolerability of three concentrations of A-101 25%, 32.5%, and 40%, when applied to individual seborrheic keratosis target lesions on the back compared with a matching A-101 vehicle.
- Conditions
- Seborrheic Keratosis (SK)
- Being tested
- A-101 25%, A-101 32.5%, A-101 40%, A-101 Vehicle
- Keywords
- SK, 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 25%Drug
Low Dose Concentration of A-101 applied to one of 4 Target Lesions
A-101 32.5%Drug
Mid Dose Concentration of A-101 applied to one of 4 Target Lesions
A-101 40%Drug
High Dose Concentration A-101 applied to one of 4 Target Lesions
A-101 VehicleDrug
Placebo applied to one of 4 Target Lesions
| Study group | Role | What they receive |
|---|---|---|
| A-101 25% | Active comparator | Low dose group Receives: Drug: A-101 25% |
| A-101 32.5% | Active comparator | Mid Dose Group Receives: Drug: A-101 32.5% |
| A-101 40% | Active comparator | High Dose Group Receives: Drug: A-101 40% |
| A-101 Vehicle | Placebo comparator | Placebo group Receives: Drug: A-101 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Physician Lesion Assessment Scale
Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion.
The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.
Measured: Visit 2 to visit 9 (78 days)
Secondary outcomes (1)
Subject's Self Assessment Scale
Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3).
Measured: Visit 9 (Day 78)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study start22 Oct 2013
- Primary completion25 Feb 2014
- Study completion25 Feb 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 Keratosis (SK)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The three tests solutions and the placebo solution are each applied topically to 1 of 4 target lesions on the backs of each subject (determined by the randomization schedule). If needed a second treatment may be applied at Visit 5.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet Dubois, MD, Principal investigator, Derm Research, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986920
- Sponsor's protocol ID
- A-101-SEBK-201
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2013
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled, Within-Subject, Comparison Study of the Safety, Tolerability, And Effectiveness of A-101 Topical Solution in Subjects With Seborrheic Keratosis
- ClinicalTrials.gov ID
- NCT01986920
- Acronym / sponsor ID
- A-101-SEBK-201
- Conditions
- Seborrheic Keratosis (SK)
- Keywords
- SK, Seborrheic Keratosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2013
- Primary completion
- 25 Feb 2014 (actual)
- Study completion
- 25 Feb 2014 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Posted 11 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.
Detailed description
The main objective of this study is to evaluate the safety, effectiveness and tolerability of three concentrations of A-101 25%, 32.5%, and 40%, when applied to individual seborrheic keratosis target lesions on the back compared with a matching A-101 vehicle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The three tests solutions and the placebo solution are each applied topically to 1 of 4 target lesions on the backs of each subject (determined by the randomization schedule). If needed a second treatment may be applied at Visit 5.
| Arm | Type | Receives |
|---|---|---|
| A-101 25% | Active comparator | Drug: A-101 25%Low dose group |
| A-101 32.5% | Active comparator | Drug: A-101 32.5%Mid Dose Group |
| A-101 40% | Active comparator | Drug: A-101 40%High Dose Group |
| A-101 Vehicle | Placebo comparator | Drug: A-101 VehiclePlacebo group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is at least 18 years of age
- Has a clinical diagnosis of stable clinically typical seborrheic keratosis
- Has at least 4 appropriate seborrheic keratosis target lesions on the back
- If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study
- Is non-pregnant and non-lactating
Key exclusion criteria (22 listed)
- Has clinically atypical and/or rapidly growing seborrheic keratosis lesions
- Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
- Has used any of the following systemic therapies within the specified period prior to Visit 1:
- Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1:
- Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days 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 25%Low Dose Concentration of A-101 applied to one of 4 Target Lesions | Drug | A-101 25% |
| A-101 32.5%Mid Dose Concentration of A-101 applied to one of 4 Target Lesions | Drug | A-101 32.5% |
| A-101 40%High Dose Concentration A-101 applied to one of 4 Target Lesions | Drug | A-101 40% |
| A-101 VehiclePlacebo applied to one of 4 Target Lesions | Drug | A-101 Vehicle |
Primary outcome
Mean Change in Physician Lesion Assessment Scale
Time frame: Visit 2 to visit 9 (78 days)
Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion. The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.
1 secondary outcome
Subject's Self Assessment Scale
Time frame: Visit 9 (Day 78)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Seborrheic Keratosis (SK)
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.
Janet Dubois, MD principal investigator
Derm Research, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A-101 25%, A-101 32.5% and A-101 40% in people with Seborrheic Keratosis (SK), 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 8 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 11 Dec 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 11 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 Change in Physician Lesion Assessment Scale (time frame: Visit 2 to visit 9 (78 days)). 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 11 Dec 2018.