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NCT01694810 · ClinicalTrials.gov registry record · Phase 1

Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers

A Phase 1 study of Acne Vulgaris, sponsored by Novan.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT01694810: Completed Phase 1 study of Acne Vulgaris, sponsored by Novan.

NCT01694810 is a Phase 1 study of Acne Vulgaris that has completed, run by Novan. The registered enrollment target is 60 participants, below the 274-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01694810, a Phase 1 study of Acne Vulgaris, has completed, sponsored by Novan.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

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).

Primary Outcome

Cutaneous tolerability evaluations to include erythema, scaling, dryness, puritus and burning/stinging using a 4-category scale with scores ranging from 0-3 (0=none, 1=mild, 2=moderate, 3 - severe).

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

FieldValue
Enrollment Target 60 participants
Start Date 2012-09
Est. Completion 2012-11
Phase Phase 1
Novan

18 total trials

What the finished NCT01694810 record still lists

NCT01694810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 274-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (78% lower).

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.

NCT01694810 reports a single indexed study location in Pennsylvania.

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.

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).

Who is sponsoring clinical trial NCT01694810?

This trial is sponsored by Novan, which has 18 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Acne Vulgaris

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01694810's enrollment target sits among peer trials

60 42nd of 67 higher than 26 of 67 other Acne Vulgaris trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acne Vulgaris trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01694810, the US trial registry maintained by the National Library of Medicine. NCT01694810 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.