search
Back to results

A Novel Combination Oral Agent to Treat Acne Vulgaris

Primary Purpose

ACNE VULGARIS

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Doxycycline and S-equol
Doxycycline
Sponsored by
Nexgen Dermatologics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACNE VULGARIS

Eligibility Criteria

13 Years - 60 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy females 13 years of age or older
  • Non-pregnant, non-lactating females
  • Signed written informed consent form
  • Must be able to understand and be willing to follow all study instructions
  • Have a clinical diagnosis of acne vulgaris

Exclusion Criteria:

  • Female subjects who are pregnant or nursing
  • Any concomitant dermatologic condition that may affect outcome measures
  • Concurrent use of any other medication to treat acne vulgaris
  • Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study
  • Are currently using any other investigational agent or device
  • Have participated in any other clinical study within 90 days prior to enrollment
  • Employees or family members of sponsor or research site

Sites / Locations

  • Palos Verdes Dermatology AssociatesRecruiting
  • Berlin CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oral antibiotic plus soy extract

Oral antibiotic

Arm Description

Outcomes

Primary Outcome Measures

The mean number of Inflammatory Lesions on the face at the beginning and end of treatment
The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.

Secondary Outcome Measures

The mean number of Comedones will be evaluated at the beginning and end of treatment
A trained investigator will count the number of comedones at the beginning and end of treatment.

Full Information

First Posted
February 16, 2011
Last Updated
February 18, 2011
Sponsor
Nexgen Dermatologics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01301586
Brief Title
A Novel Combination Oral Agent to Treat Acne Vulgaris
Official Title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL ORAL ACNE TREATMENT FOR THE TREATMENT OF ACNE VULGARIS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nexgen Dermatologics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACNE VULGARIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral antibiotic plus soy extract
Arm Type
Active Comparator
Arm Title
Oral antibiotic
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Doxycycline and S-equol
Intervention Description
Oral doxycycline and s-equol twice a day
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
ORAL DOXYCYCLINE TWICE A DAY
Primary Outcome Measure Information:
Title
The mean number of Inflammatory Lesions on the face at the beginning and end of treatment
Description
The number of inflammatory lesions will be counted by a trained investigator at the beginning and end of treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The mean number of Comedones will be evaluated at the beginning and end of treatment
Description
A trained investigator will count the number of comedones at the beginning and end of treatment.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy females 13 years of age or older Non-pregnant, non-lactating females Signed written informed consent form Must be able to understand and be willing to follow all study instructions Have a clinical diagnosis of acne vulgaris Exclusion Criteria: Female subjects who are pregnant or nursing Any concomitant dermatologic condition that may affect outcome measures Concurrent use of any other medication to treat acne vulgaris Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study Are currently using any other investigational agent or device Have participated in any other clinical study within 90 days prior to enrollment Employees or family members of sponsor or research site
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
H G Berlin, ESQ
Phone
561-739-5252
Email
garyberlin17@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua M Berlin, MD
Organizational Affiliation
Study Protocol, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palos Verdes Dermatology Associates
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Fein, MD
Phone
310-541-7800
First Name & Middle Initial & Last Name & Degree
HOWARD FEIN, MD
Facility Name
Berlin Center
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H G Berlin, ESQ
Phone
561-739-5252
Email
garyberlin17@hotmail.com
First Name & Middle Initial & Last Name & Degree
Joshua M Berlin, MD

12. IPD Sharing Statement

Learn more about this trial

A Novel Combination Oral Agent to Treat Acne Vulgaris

We'll reach out to this number within 24 hrs