Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne

ClinicalTrials.gov ID: NCT00031096

Public ClinicalTrials.gov record NCT00031096. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 22, 2026, 2:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 12-week, Randomized, Double-blind, Multicenter Study Comparing the Clinical Efficacy and Safety of Azelaic Acid 15% Gel (SH H 655 BA) With Its Vehicle (SH H 655 PBA) in Patients With Mild to Moderate Acne.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.

Study identification

NCT ID: NCT00031096
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: LEO Pharma; Industry
Enrollment: 879 participants

Conditions and interventions

Conditions

Acne Vulgaris

Interventions

Drug

Eligibility (public fields only)

Age range: 12 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 2002 (Type not available)
Primary completion: Jul 2002 (Actual)
Completion: Jul 2002 (Actual)
Last update posted: Jun 9, 2023

2002

United States locations

U.S. sites: 16
U.S. states: 14
U.S. cities: 16

Facility	City	State	ZIP	Site status
Not listed	Mobile	Alabama	36608	—
Not listed	Boulder	Colorado	80304	—
Not listed	Newnan	Georgia	30263	—
Not listed	Shawnee Mission	Kansas	66203	—
Not listed	Wichita	Kansas	67206	—
Not listed	Lexington	Kentucky	40509	—
Not listed	Albuquerque	New Mexico	87106	—
Not listed	Bay Shore	New York	11706	—
Not listed	Winston-Salem	North Carolina	27103	—
Not listed	Cincinnati	Ohio	45230	—
Not listed	Portland	Oregon	97223-6683	—
Not listed	Hershey	Pennsylvania	17033	—
Not listed	Knoxville	Tennessee	37922	—
Not listed	Bryan	Texas	77802	—
Not listed	San Antonio	Texas	78229	—
Not listed	Seattle	Washington	98105	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00031096, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 9, 2023 · Synced Oct 22, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00031096 live on ClinicalTrials.gov.

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