AcnePhase 2NCT00419848
the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris
A Phase 2 study testing Doxycycline and Azithromycin in people with Acne, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin in the management of moderate acne vulgaris Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Doxycycline and Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Aug 2006to Feb 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 to 30 year old
- Moderate facial Acne(At least 10 inflammatory lesions with maximum 3 nodules and pseudocysts
Who cannot join
- Pregnancy
- Breast Feeding
- Acne Fulminant
- Acne conglobate
- Isotretinoin therapy within past 6 months
- topical treatment in last 2 weeks
Show all 9Show fewer
- use of systemic antibiotic in the last month
- Hyperandrogenism symptoms
- Menstrual irregularity
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shaheed Beheshti Medical University, Skin research center
Tehran, 198994148
About this study
a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin in the management of moderate acne vulgaris
- Conditions
- Acne
- Being tested
- Doxycycline, Azithromycin
- Keywords
- Acne, Azithromycin, Doxycycline
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Razak lab
Cap 100mg- 100mg/daily
AzithromycinDrug
Also called kimidarou
Azithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Azithromycin |
| 2 | Active comparator | Not described Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in acne lesions
Measured: 12 weeks
Secondary outcomes (1)
global response rates, patient's own assessment, side effects and compliance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startAug 2006
- Primary completionJan 2008 (estimated)
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Parviz Toossi, M.D., Study chair, Skin Research CenterHamideh Moravvej, M.D., Principal investigator, Skin Research CenterAkbar Mousazadeh halim, M.D., Principal investigator, Skin Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419848
- Sponsor's protocol ID
- src-hmj-1385
- Status last verified
- Jan 2008
- First submitted
- 8 Jan 2007
- Last updated
- 29 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00419848
- Acronym / sponsor ID
- src-hmj-1385
- Conditions
- Acne
- Keywords
- Acne, Azithromycin, Doxycycline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jan 2008 (estimated)
- Study completion
- Feb 2008 (estimated)
- First posted
- 9 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin in the management of moderate acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Azithromycin |
| 2 | Active comparator | Drug: Doxycycline |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between 18 to 30 year old
- Moderate facial Acne(At least 10 inflammatory lesions with maximum 3 nodules and pseudocysts
Key exclusion criteria (9 listed)
- Pregnancy
- Breast Feeding
- Acne Fulminant
- Acne conglobate
- Isotretinoin therapy within past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineAlso: Razak labCap 100mg- 100mg/daily | Drug | 2 |
| AzithromycinAlso: kimidarouAzithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week | Drug | 1 |
Primary outcome
change in acne lesions
Time frame: 12 weeks
1 secondary outcome
global response rates, patient's own assessment, side effects and compliance
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parviz Toossi, M.D. study chair
Skin Research Center
Hamideh Moravvej, M.D. principal investigator
Skin Research Center
Akbar Mousazadeh halim, M.D. principal investigator
Skin Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline and Azithromycin in people with Acne, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Parviz Toossi, M.D. (98-21-22744393 ext. 5, src@sbmu.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in acne lesions (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2008.