Dermatosis Papulosa NigraPhase 2NCT03224598
A Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra
A Phase 2 study testing A-101 Topical Solution 40% in people with Dermatosis Papulosa Nigra, run by Aclaris Therapeutics, Inc. at 2 sites in United States.
Trial summary
Evaluate the safety and efficacy of hydrogen peroxide, A-101 Solution 40% for the treatment of DPN lesions on subjects with a Fitzpatrick Skin Type of 5 or 6. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatosis Papulosa Nigra
- What is being tested?
- A-101 Topical Solution 40%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jun 2017to 8 Jan 2019
- 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
- Provisions of written informed consent for participation in this study.
- Male or female ≥ 18 years old.
- Subject has a clinical diagnosis of dermatosis papulose nigra.
- Fitzpatrick Skin Type of 5 or 6
- Subject has 4 target DPN lesions located in an area that has not been previously treated.
- Subject chemistry and complete blood count results are within normal limits for the central laboratory.
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- 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.
- 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 DPN lesion.
- Subject has current systemic malignancy.
- Subject has a history of keloids
- Subject has a history of post inflammatory hyperpigmentation lasting longer than 1 year.
- Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
- Retinoids; 180 days
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- Corticosteroids; 28 days
- Antimetabolites (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 [IPL], photo-dynamic therapy [PDT]; 180 days
- Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluoruracil (5FU), or ingenol mebutate; 60 days
- Retinoids; 28 days
- Microdermabrasion or superficial chemical peels; 14 days
- Corticosteroids 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 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. 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 with 30 days prior to Visit 1.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aclaris Investigational Site
New York, New York, 10155
Aclaris Investigational Site
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase 2 Open Label Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra
Evaluate the safety and efficacy of hydrogen peroxide, A-101 Solution 40% for the treatment of DPN lesions on subjects with a Fitzpatrick Skin Type of 5 or 6.
Read the detailed description
The main objective of this study is to evaluate the safety and efficacy of hydrogen peroxide, A-101 Solution 40% for the treatment of DPN lesions on subjects with a Fitzpatrick Skin Type of 5 or 6.
The secondary objectives of this study include:
- Durability of response
- Safety
An exploratory objective of this study will evaluate the subject's assessment of the treatment of A-101 to DPN lesions using a Subject Self-Assessment Scale.
- Conditions
- Dermatosis Papulosa Nigra
- Being tested
- A-101 Topical Solution 40%
- Medical subject headings
- Dermatosis Papulosa Nigra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-101 Topical Solution 40%Drug
A-101 Topical Solution 40%
| Study group | Role | What they receive |
|---|---|---|
| No medical abrading | Experimental | A-101 40% without medically abrading the identified DPN prior to treatment Receives: Drug: A-101 Topical Solution 40% |
| Medically abrading | Experimental | A-101 40% with the identified DPN lesions medically abraded prior to treatment Receives: Drug: A-101 Topical Solution 40% |
| Initial cohort - no medical abrading | Experimental | A-101 40% without medically abrading the identified DPN prior to treatment Receives: Drug: A-101 Topical Solution 40% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's DPN Lesions Assessment
Efficacy endpoints will include summary statistics (frequency distributions, proportions, means, medians and standard deviations, as appropriate) by visit for the following parameters: Physician's DPN Lesion Assessment scale results per treated lesion, subject responders defined by Physician's DPN Lesion Assessment scale outcome, and changes from baseline treated lesion diameter
Physician's DPN Lesion Assessment Grade Descriptor 0 Clear: no visible DPN lesion;
- Near Clear: a slightly visible DPN lesion; lesion may be macular
- Small: a visible DPN lesion with a diameter of less than 3 mm
- Large : a visible DPN lesion that is elevated with a diameter of ≥3 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 posted21 Jul 2017
- Study start26 Jun 2017
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
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 Dermatosis Papulosa NigraStudies 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
- Model description
- The first cohort of the study will enroll a total of 12 subjects. In the second part of the study, subjects will be a randomized to additional two-arm cohorts. Subjects will be randomized to one of the following 2 treatment arms: * A-101 40% without medically abrading the identified DPN prior to treatment * A-101 40% with the identified DPN lesions medically abraded prior to treatment
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224598
- Sponsor's protocol ID
- A-101-DPN-201
- Status last verified
- Feb 2020
- First submitted
- 5 Jul 2017
- Last updated
- 30 Mar 2020
- 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 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open Label Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra
- ClinicalTrials.gov ID
- NCT03224598
- Acronym / sponsor ID
- A-101-DPN-201
- Conditions
- Dermatosis Papulosa Nigra
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 17 Mar 2020
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 and efficacy of hydrogen peroxide, A-101 Solution 40% for the treatment of DPN lesions on subjects with a Fitzpatrick Skin Type of 5 or 6.
Detailed description
The main objective of this study is to evaluate the safety and efficacy of hydrogen peroxide, A-101 Solution 40% for the treatment of DPN lesions on subjects with a Fitzpatrick Skin Type of 5 or 6.
The secondary objectives of this study include:
- Durability of response
- Safety
An exploratory objective of this study will evaluate the subject's assessment of the treatment of A-101 to DPN lesions using a Subject Self-Assessment Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The first cohort of the study will enroll a total of 12 subjects. In the second part of the study, subjects will be a randomized to additional two-arm cohorts. Subjects will be randomized to one of the following 2 treatment arms: * A-101 40% without medically abrading the identified DPN prior to treatment * A-101 40% with the identified DPN lesions medically abraded prior to treatment
| Arm | Type | Receives |
|---|---|---|
| No medical abrading | Experimental | Drug: A-101 Topical Solution 40%A-101 40% without medically abrading the identified DPN prior to treatment |
| Medically abrading | Experimental | Drug: A-101 Topical Solution 40%A-101 40% with the identified DPN lesions medically abraded prior to treatment |
| Initial cohort - no medical abrading | Experimental | Drug: A-101 Topical Solution 40%A-101 40% without medically abrading the identified DPN prior to treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provisions of written informed consent for participation in this study.
- Male or female ≥ 18 years old.
- Subject has a clinical diagnosis of dermatosis papulose nigra.
- Fitzpatrick Skin Type of 5 or 6
- Subject has 4 target DPN lesions located in an area that has not been previously treated.
Key exclusion criteria (23 listed)
- Subject has clinically atypical and /or rapidly growing DPN lesion.
- Subject has current systemic malignancy.
- Subject has a history of keloids
- Subject has a history of post inflammatory hyperpigmentation lasting longer than 1 year.
- 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 Topical Solution 40%A-101 Topical Solution 40% | Drug | Initial cohort - no medical abrading, Medically abrading, No medical abrading |
Primary outcome
Physician's DPN Lesions Assessment
Time frame: Day 106
Efficacy endpoints will include summary statistics (frequency distributions, proportions, means, medians and standard deviations, as appropriate) by visit for the following parameters: Physician's DPN Lesion Assessment scale results per treated lesion, subject responders defined by Physician's DPN Lesion Assessment scale outcome, and changes from baseline treated lesion diameter Physician's DPN Lesion Assessment Grade Descriptor 0 Clear: no visible DPN lesion; 1. Near Clear: a slightly visible DPN lesion; lesion may be macular 2. Small: a visible DPN lesion with a diameter of less than 3 mm 3. Large : a visible DPN lesion that is elevated with a diameter of ≥3 mm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Topical Solution 40% in people with Dermatosis Papulosa Nigra, run by Aclaris Therapeutics, Inc. at 2 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 10 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 17 Mar 2020). 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?
Physician's DPN Lesions Assessment (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 30 Mar 2020.