Trials / Completed
CompletedNCT03653403
Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel
A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 9 Years
- Healthy volunteers
- Not accepted
Summary
This will be an open-label study designed to assess the safety and plasma PK of topically applied IDP-126 Gel compared to Control Gel.
Detailed description
To evaluate the safety and plasma pharmacokinetics (PK) of clindamycin and adapalene in IDP-126 Gel compared with that from Control Gel in subjects with moderate to severe acne vulgaris (acne) during once daily topical application of IDP-126 Gel for 28 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IDP-126 Gel | Component A |
| DRUG | Control Gel | gel |
Timeline
- Start date
- 2018-08-08
- Primary completion
- 2019-06-19
- Completion
- 2019-06-19
- First posted
- 2018-08-31
- Last updated
- 2019-10-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03653403. Inclusion in this directory is not an endorsement.