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

Phase 2

Completed

Conditions: Dermatosis Papulosa Nigra

Interventions: Drug: A-101 Topical Solution 40%

Registration Number: NCT03224598

Lead Sponsor: Aclaris Therapeutics, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

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

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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