A Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra
Condition: Dermatosis Papulosa Nigra
MeSH terms: Skin Diseases; Skin Diseases, Papulosquamous
Intervention: A-101 Topical Solution 40%
Intervention description: A-101 Topical Solution 40%
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.