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Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
NCT01694810 · View on ClinicalTrials.gov ↗
Study Summary
The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).
Conditions Studied
Interventions
- DRUG 2% NVN1000 Topical Gel
- DRUG 4% NVN1000 Topical Gel
- DRUG 8% NVN1000 Topical Gel
- DRUG Vehicle Topical Gel
Study Locations (1)
Pennsylvania
- KGL, Inc — Broomall
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01694810
The ClinicalTrials.gov registry entry for NCT01694810 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novan, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 4 interventions — of which 2% NVN1000 Topical Gel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01694810 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01694810 about?
NCT01694810 is a clinical study titled "Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers". The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks...
What is the current status of trial NCT01694810?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2012-09. Estimated completion is 2012-11.
What conditions does trial NCT01694810 study?
This clinical trial studies the following conditions: Acne Vulgaris. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01694810?
The interventions under investigation include: 2% NVN1000 Topical Gel (DRUG), 4% NVN1000 Topical Gel (DRUG), 8% NVN1000 Topical Gel (DRUG), Vehicle Topical Gel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01694810?
This trial is sponsored by Novan, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01694810 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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