Combination Treatment for Moderate to Severe Acne | NCT01206348

Studies
Combination Treatment for Moderate to Severe Acne

NCT01206348

Sponsor

Medicis Global Service Corporation

Status

Completed

Last Update Posted

Nov 30, 2011Estimated

Enrollment

97Actual

Phase

Phase 4

Conditions

Acne

Interventions

Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide

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

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Sep 17, 2010

First Submission Date that Met QC Criteria

Sep 20, 2010

First Posted Date

Sep 21, 2010Estimated

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

Nov 28, 2011

Last Update Posted Date

Nov 30, 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

To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne

Detailed Description

A Phase IV, Open-Label Study Evaluating the treatment for Combination Acne Therapy.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open Label Combination	Experimental	Solodyn, Ziana, Triaz FC	Drug: Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide	Drug	Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night	Open Label Combination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients showing improvement from Baseline and Week 12		Week 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)

Exclusion Criteria:

pregnancy and allergies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Sanstead, BSN, CCRP	Medicis Global Service Corporation	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		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
D008911	Minocycline
D002981	Clindamycin
D014212	Tretinoin
D001585	Benzoyl Peroxide

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided