the Comparison Efficacy of Azithromycin With Doxycycline... | NCT00419848

Studies
the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris

NCT00419848

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Jan 29, 2008Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Acne

Interventions

Doxycycline
Azithromycin

Countries

Iran

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

Jan 2008

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

Aug 2006

Primary Completion Date

Jan 2008Estimated

Completion Date

Feb 2008Estimated

First Submitted Date

Jan 8, 2007

First Submission Date that Met QC Criteria

Jan 8, 2007

First Posted Date

Jan 9, 2007Estimated

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

Jan 28, 2008

Last Update Posted Date

Jan 29, 2008Estimated

Description Module

Brief Summary

a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin in the management of moderate acne vulgaris

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Azithromycin
2	Active Comparator		Drug: Doxycycline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxycycline	Drug	Cap 100mg- 100mg/daily	2	Razak lab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in acne lesions		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
global response rates, patient's own assessment, side effects and compliance		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between 18 to 30 year old
Moderate facial Acne(At least 10 inflammatory lesions with maximum 3 nodules and pseudocysts

Exclusion Criteria:

Pregnancy
Breast Feeding
Acne Fulminant
Acne conglobate
Isotretinoin therapy within past 6 months
topical treatment in last 2 weeks
use of systemic antibiotic in the last month
Hyperandrogenism symptoms
Menstrual irregularity

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Parviz Toossi, M.D.	Contact	98-21-22744393	5	src@sbmu.ac.ir

Overall Officials

Name	Affiliation	Role
Parviz Toossi, M.D.	Skin Research Center	Study Chair
Hamideh Moravvej, M.D.	Skin Research Center	Principal Investigator
Akbar Mousazadeh halim, M.D.

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaheed Beheshti Medical University, Skin research center	Recruiting	Tehran		198994148	Iran

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
D017963	Azithromycin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided