NCT03224598

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatosis Papulosa Nigra

Interventions

Type	Name	Description
DRUG	A-101 Topical Solution 40%	A-101 Topical Solution 40%

Timeline

• Start date: 2017-06-26
• Primary completion: 2019-01-08
• Completion: 2019-01-08
• First posted: 2017-07-21
• Last updated: 2020-03-30
• Results posted: 2020-03-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study