A Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra
Status: | Active, not recruiting |
---|---|
Conditions: | Skin and Soft Tissue Infections |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/5/2018 |
Start Date: | June 26, 2017 |
End Date: | December 2018 |
A Phase 2 Open Label, Single Arm Pilot 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.
of DPN lesions on subjects with a Fitzpatrick Skin Type of 5 or 6.
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.
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.
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. Subject chemistry and complete blood count results are within normal limits for the
central laboratory. If any of the laboratory values are outside normal limits, the
treating investigator must assess the value/s as not clinically significant and
document this in the patient's source documents.
5. 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
6. Subject is non-pregnant and non-lactating.
7. Subject is in good general health and free of any known disease state or physical
condition which, in the investigator's opinion, might impair the evaluation of any
Target DPN Lesions or which exposes the subject to an unacceptable risk by study
participation.
8. 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-flurouracil (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.
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