A Novel Combination Oral Agent to Treat Acne Vulgaris | NCT01301586

Studies
A Novel Combination Oral Agent to Treat Acne Vulgaris

NCT01301586

Sponsor

Nexgen Dermatologics, Inc.

Status

Unknown status

Last Update Posted

Feb 23, 2011Estimated

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

ACNE VULGARIS

Interventions

Doxycycline and S-equol
Doxycycline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Sep 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Feb 16, 2011

First Submission Date that Met QC Criteria

Feb 18, 2011

First Posted Date

Feb 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2011

Last Update Posted Date

Feb 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral antibiotic plus soy extract	Active Comparator		Drug: Doxycycline and S-equol
Oral antibiotic	Active Comparator		Drug: Doxycycline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxycycline and S-equol	Drug	Oral doxycycline and s-equol twice a day	Oral antibiotic plus soy extract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
H G Berlin, ESQ	Contact	561-739-5252		garyberlin17@hotmail.com

Overall Officials

Name	Affiliation	Role
Joshua M Berlin, MD	Study Protocol, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Palos Verdes Dermatology Associates	Recruiting	Rolling Hills Estates	California	90274	United States

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004318	Doxycycline
D060754	Equol

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided