Dermatosis Papulosa Nigra
Conditions
Brief 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.
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.
Interventions
DRUGA-101 Topical Solution 40%
A-101 Topical Solution 40%
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provisions of written informed consent for participation in this study. 2. Male or female ≥ 18 years old. 3. Subject has a clinical diagnosis of dermatosis papulose nigra. 4. Fitzpatrick Skin Type of 5 or 6 5. Subject has 4 target DPN lesions located in an area that has not been previously treated. 6. Subject chemistry and complete blood count results are within normal limits for the central laboratory. 7. 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 8. Subject is non-pregnant and non-lactating. 9. Subject is in good general health and free of any known disease state or physical condition. 10. Subject is willing and able to follow all study instructions and to attend all study visits.
Exclusion criteria
1. Subject has clinically atypical and /or rapidly growing DPN lesion. 2. Subject has current systemic malignancy. 3. Subject has a history of keloids 4. Subject has a history of post inflammatory hyperpigmentation lasting longer than 1 year. 5. Subject has used any of the following systemic therapies within the specified period prior to Visit 1: * Retinoids; 180 days * Corticosteroids; 28 days * Antimetabolites (e.g., methotrexate); 28 days 6. 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. 7. 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. 8. Subject has a history of sensitivity to any of the ingredients in the study medications. 9. 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. 10. Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician's DPN Lesions Assessment | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Medical Abrading A-101 40% without medically abrading the identified DPN prior to treatment
A-101 Topical Solution 40%: A-101 Topical Solution 40% | 9 |
| Medically Abrading A-101 40% with the identified DPN lesions medically abraded prior to treatment
A-101 Topical Solution 40%: A-101 Topical Solution 40% | 17 |
| Initial Cohort - no Medical Abrading A-101 40% without medically abrading the identified DPN prior to treatment
A-101 Topical Solution 40%: A-101 Topical Solution 40%
initial cohort no medical abrading different treatment schedule | 13 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 0 |
| Overall Study | Other | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | No Medical Abrading | Medically Abrading | Initial Cohort - no Medical Abrading | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 6 Participants | 7 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 11 Participants | 6 Participants | 22 Participants |
| Fitzpatrick Skin Type fitzpatrick 5: Rarely burns, tans darkly easily | 7 Participants | 10 Participants | 8 Participants | 25 Participants |
| Fitzpatrick Skin Type fitzpatrick 6: Never burns, always tans darkly | 2 Participants | 7 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 16 Participants | 13 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 9 participants | 17 participants | 13 participants | 39 participants |
| Sex: Female, Male Female | 8 Participants | 13 Participants | 8 Participants | 29 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 17 | 0 / 13 |
| other Total, other adverse events | 1 / 9 | 2 / 17 | 1 / 13 |
| serious Total, serious adverse events | 0 / 9 | 0 / 17 | 0 / 13 |
Outcome results
Primary
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; 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
Time frame: Day 106
Population: per-protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Medical Abrading | Physician's DPN Lesions Assessment | -0.75 score on a scale (PLA) | Standard Deviation 0.52 |
| Medically Abrading | Physician's DPN Lesions Assessment | -1.38 score on a scale (PLA) | Standard Deviation 0.9 |
| Initial Cohort - no Medical Abrading | Physician's DPN Lesions Assessment | -0.92 score on a scale (PLA) | Standard Deviation 0.95 |