A Novel Combination Oral Agent to Treat Acne Vulgaris

NCT ID: NCT01301586

Last Updated: 2011-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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Conditions

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ACNE VULGARIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oral antibiotic plus soy extract

Group Type ACTIVE_COMPARATOR

Doxycycline and S-equol

Intervention Type DRUG

Oral doxycycline and s-equol twice a day

Oral antibiotic

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

ORAL DOXYCYCLINE TWICE A DAY

Interventions

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Doxycycline and S-equol

Oral doxycycline and s-equol twice a day

Intervention Type DRUG

Doxycycline

ORAL DOXYCYCLINE TWICE A DAY

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nexgen Dermatologics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Nexgen Dermatologics, Inc.

Principal Investigators

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Joshua M Berlin, MD

Role: PRINCIPAL_INVESTIGATOR

Study Protocol, Inc.

Locations

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Palos Verdes Dermatology Associates

Rolling Hills Estates, California, United States

Site Status RECRUITING

Berlin Center

Boynton Beach, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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H G Berlin, ESQ

Role: CONTACT

561-739-5252

Facility Contacts

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Howard Fein, MD

Role: primary

310-541-7800

H G Berlin, ESQ

Role: primary

561-739-5252

Other Identifiers

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11022006

Identifier Type: -

Identifier Source: org_study_id

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