NCT02250430

Brief Summary

In this study, color (erythema) and pH will be measured on 3 consecutive days after application of 2 doses of SB204 to the cheeks of healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

Same day

First QC Date

September 10, 2014

Last Update Submit

November 15, 2018

Conditions

Acne Vulgaris

Keywords

acne

Outcome Measures

Primary Outcomes (2)

  • Intensity of erythema following application of SB204 2% and SB204 4%.

    3 days

  • Duration of erythema following application of SB204 2% and SB204 4%.

    3 days

Secondary Outcomes (1)

  • pH on the surface of the skin after topical application of 2 concentrations of SB204

    3 days

Study Arms (1)

Topical SB204

EXPERIMENTAL

Topical application of SB204 2% and 4% twice daily for 2 days and once on Day 3

Drug: SB204

Interventions

SB204DRUG

Applied topically twice a day on days 1, 2 and 3 to left and right cheeks

Also known as: NVN1000
Topical SB204

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Women who are pregnant or nursing
  • Subject with known sensitivity to a component of the test materials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KGL

Broomall, Pennsylvania, 19008, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

berdazimer sodium

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Stuart Lessin, MD

    KGL, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 26, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations

US(1)