A Phase 1 Study Assessing Local Cutaneous Effects of SB204

A Phase 1, Single-Center, Split-Face Study Assessing Local Cutaneous Effects After Application of SB204 2% and SB204 4% in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02250430

Enrollment

Registered

2014-09-26

Start date

2014-09-30

Completion date

2014-09-30

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

acne

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.

Detailed description

This study is to evaluate local cutaneous effects, including intensity and duration of erythema and changes in pH following 5 applications (twice daily for two days and once daily on the third day) of SB204 2% and SB204 4% twice daily to the face for 3 days.

Interventions

DRUGSB204

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
pH on the surface of the skin after topical application of 2 concentrations of SB204	3 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026