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

Dermatosis Papulosa Nigra Clinical Trial

Official title:

A Phase 2 Open Label Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224598
• Other study ID #: A-101-DPN-201
• Status: Completed
• Phase: Phase 2
• Start date: June 26, 2017
• Est. completion date: January 8, 2019

Study information

• Verified date: February 2020
• Source: Aclaris Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatosis Papulosa Nigra
• Skin Diseases
• Skin Diseases, Papulosquamous

Intervention

Drug:
• A-101 Topical Solution 40%
A-101 Topical Solution 40%

Locations

Country	Name	City	State
United States	Aclaris Investigational Site	New York	New York
United States	Aclaris Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Aclaris Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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; Near Clear: a slightly visible DPN lesion; lesion may be macular; Small: a visible DPN lesion with a diameter of less than 3 mm; Large : a visible DPN lesion that is elevated with a diameter of =3 mm	Day 106