CompletedNCT03224598Updated Mar 30, 2020Results posted

A Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra

A Phase 2 interventional study of A-101 Topical Solution 40% in Dermatosis Papulosa Nigra, sponsored by Aclaris Therapeutics, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by Aclaris Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 39
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Dermatosis Papulosa Nigra

Browse trials for

Skin Diseases 537

In context

Skin Diseases

537 studies on the registry are indexed under Skin Diseases; 91 are open to participants now.

This study's enrollment of 39 is below the median of 60 across 371 interventional studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

Aclaris Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 22 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.
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.

Exclusion criteria

Exclusion Criteria:

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
- 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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 39 participants (actual)

Study arms

Experimental
No medical abrading
A-101 40% without medically abrading the identified DPN prior to treatment
Drug: A-101 Topical Solution 40%
Experimental
Medically abrading
A-101 40% with the identified DPN lesions medically abraded prior to treatment
Drug: A-101 Topical Solution 40%
Experimental
Initial cohort - no medical abrading
A-101 40% without medically abrading the identified DPN prior to treatment
Drug: A-101 Topical Solution 40%

Interventions

DrugA-101 Topical Solution 40%
A-101 Topical Solution 40%

What researchers measure

Primary outcomes

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

Results

Posted Mar 17, 2020

Participant flow

Participant flow — Overall Study
Milestone	No Medical Abrading	Medically Abrading	Initial Cohort - no Medical Abrading
Started	9	17	13
Completed	9	14	13
Not completed	0	3	0
Withdrew: Lost to follow-up	0	2	0
Withdrew: Other	0	1	0

Outcome measures

PrimaryPhysician'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
Reported as:: Mean · score on a scale (PLA)

Physician's DPN Lesions Assessment
score on a scale (PLA)	No Medical Abrading	Medically Abrading	Initial Cohort - no Medical Abrading
Physician's DPN Lesions Assessment	-0.75 ± 0.52	-1.38 ± 0.90	-0.92 ± 0.95

Adverse events

Collected over 106 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
No Medical Abrading	0/9 (0%)	0/9 (0%)	1/9 (11.1%)
Medically Abrading	0/17 (0%)	0/17 (0%)	2/17 (11.8%)
Initial Cohort - no Medical Abrading	0/13 (0%)	0/13 (0%)	1/13 (7.7%)

Most frequent other events

Most frequent other events
Event	No Medical Abrading	Medically Abrading	Initial Cohort - no Medical Abrading
Muscle strainMusculoskeletal and connective tissue disorders	1/9	0/17	0/13
eye painEye disorders	0/9	0/17	1/13
Lacrimation increasedEye disorders	0/9	0/17	1/13
headacheNervous system disorders	0/9	0/17	1/13
Upper respiratory tract infectionInfections and infestations	0/9	1/17	0/13
Rash vesicularSkin and subcutaneous tissue disorders	0/9	1/17	0/13

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	No Medical Abrading	Medically Abrading	Initial Cohort - no Medical Abrading	Total
<=18 years	0	0	0	0
Between 18 and 65 years	5	11	6	22
>=65 years	4	6	7	17

Sex: Female, Male
Sex: Female, Male(Participants)	No Medical Abrading	Medically Abrading	Initial Cohort - no Medical Abrading	Total
Female	8	13	8	29
Male	1	4	5	10

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	No Medical Abrading	Medically Abrading	Initial Cohort - no Medical Abrading	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	9	16	13	38
White	0	1	0	1
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	No Medical Abrading	Medically Abrading	Initial Cohort - no Medical Abrading	Total
United States	9	17	13	39

Fitzpatrick Skin Type
Fitzpatrick Skin Type(Participants)	No Medical Abrading	Medically Abrading	Initial Cohort - no Medical Abrading	Total
fitzpatrick 5: Rarely burns, tans darkly easily	7	10	8	25
fitzpatrick 6: Never burns, always tans darkly	2	7	5	14

Study locations

2 sites

Aclaris Investigational Site
Washington, District of Columbia 20037, United States
Aclaris Investigational Site
New York, New York 10155, United States

References and documents

Study documents

Study protocol · Mar 28, 2018
Statistical analysis plan · Feb 19, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03224598
Lead sponsor: Aclaris Therapeutics, Inc.
Responsible party: Sponsor
First posted: Jul 21, 2017
Start date: Jun 26, 2017
Primary completion: Jan 8, 2019
Completion: Jan 8, 2019
Results posted: Mar 17, 2020
Last update: Mar 30, 2020

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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