NCT00419848

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

January 29, 2008

Status Verified

January 1, 2008

Enrollment Period

1.4 years

First QC Date

January 8, 2007

Last Update Submit

January 28, 2008

Conditions

Acne

Keywords

AcneAzithromycinDoxycycline

Outcome Measures

Primary Outcomes (1)

  • change in acne lesions

    12 weeks

Secondary Outcomes (1)

  • global response rates, patient's own assessment, side effects and compliance

    12 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Azithromycin

2

ACTIVE COMPARATOR
Drug: Doxycycline

Interventions

DoxycyclineDRUG

Cap 100mg- 100mg/daily

Also known as: Razak lab
2
AzithromycinDRUG

Azithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week

Also known as: kimidarou
1

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Beheshti Medical University, Skin research center

Tehran, 198994148, Iran

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

DoxycyclineAzithromycin

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsErythromycinMacrolidesPolyketidesLactones

Study Officials

  • Parviz Toossi, M.D.

    Skin Research Center

    STUDY CHAIR

  • Hamideh Moravvej, M.D.

    Skin Research Center

    PRINCIPAL INVESTIGATOR

  • Akbar Mousazadeh halim, M.D.

    Skin Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Parviz Toossi, M.D.

CONTACT

98-21-22744393src@sbmu.ac.ir

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 9, 2007

Study Start

August 1, 2006

Primary Completion

January 1, 2008

Study Completion

February 1, 2008

Last Updated

January 29, 2008

Record last verified: 2008-01

Locations

IR(1)