AcnePhase 2/3NCT01348321
Comparison of Efficacy of Azithromycin and Levamisole Versus of Azithromycin in in the Treatment of Acne
A Phase 2/3 study testing Levamisole in people with Acne, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.
Trial summary
Different immunologic mechanisms contribute to development of inflammation in acne vulgaris and immunologic effect of levamisole has been demonstrated. Objective: The aim of this study was to compare azithromycin and levamisole with azithromycin alone in the treatment of acne vulgaris. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Levamisole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteIran
- Study dates
- Nov 2008to Oct 2009
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who had at least 20 papules and/or pustules,
- Patients with nodule and/or cyst disregarding the number of papules of pustules, were included the study. There was not any age limit
Who cannot join
- were using any type of systemic treatment for their acne at the time of visit or during the last month;
- had any hematological, renal or hepatic disease
- were pregnant or lactating;
- had drug-induced acne;
- were using alcohol, anti-convulsants or anti-coagulants.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Azadegan Street,Imam Hospital,Department of Dermatology
Ahvāz, Khoozestan, 6193673166
About this study
Official title: Superior Efficacy of Azithromycin and Levamisole Versus of Azithromycin Alone in the Treatment of Inflammatory Acne Vulgaris: An Investigator Blind Randomized Clinical Trial on 169 Patients
Different immunologic mechanisms contribute to development of inflammation in acne vulgaris and immunologic effect of levamisole has been demonstrated.
Objective: The aim of this study was to compare azithromycin and levamisole with azithromycin alone in the treatment of acne vulgaris.
Read the detailed description
An investigator blind clinical randomized prospective two months study was designed. One hundred sixty nine acne patients presenting in our outpatients clinic were randomly allocated to two treatment groups: azithromycin and levamisole ( group 1 ) and azithromycin alone ( group 2 ) .One hundred forty eight patients completed the duration of the study and their clinical responses were evaluated and compared by using monthly photographic records .
- Conditions
- Acne
- Being tested
- Levamisole
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevamisoleDrug
Group 1: Azithromycin 500 mg per day, three days a week plus oral levamisole 150 mg per day, two days a week. Group 2: Azithromycin 500 mg per day, three days a week. The used medications were not revealed to their physician. A questionnaire was filled for every patient and photos were taken from lesions using a digital camera at first, second and final visit.
| Study group | Role | What they receive |
|---|---|---|
| Azithromicine plus levamisole | Experimental | Not described Receives: Drug: Levamisole |
| Azithromicin | Experimental | Not described Receives: Drug: Levamisole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
A questionnaire was filled for every patient.For patients in both groups, lab tests were done at each visit.All adverse effect and the number of them were recorded and the patients who had side-effects or didn't follow the visits were excluded from the study.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startNov 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahvaz Jundishapur University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Sima Rasaii, Dermtologist, Principal investigator, Jundishapur University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348321
- Sponsor's protocol ID
- Acne and levamisole
- Other IDs
- 126/د
- Status last verified
- Oct 2008
- First submitted
- 25 Apr 2011
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haneke E. [Levamisole treatment of acne fulminans (author's transl)]. Z Hautkr. 1981 Sep 1;56(17):1160-6. German.
PubMed 6457452Ansarin H, Savabynasab S, Behzadi AH, Sadigh N, Hasanloo J. Doxycycline plus levamisole: combination treatment for severe nodulocystic acne. J Drugs Dermatol. 2008 Aug;7(8):737-40.
PubMed 18720689Rassai S, Mehri M, Yaghoobi R, Sina N, Mohebbipour A, Feily A. Superior efficacy of azithromycin and levamisole vs. azithromycin in the treatment of inflammatory acne vulgaris: an investigator blind randomized clinical trial on 169 patients. Int J Clin Pharmacol Ther. 2013 Jun;51(6):490-4. doi: 10.5414/CP201861.
PubMed 23547851
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Efficacy of Azithromycin and Levamisole Versus of Azithromycin Alone in the Treatment of Inflammatory Acne Vulgaris: An Investigator Blind Randomized Clinical Trial on 169 Patients
- ClinicalTrials.gov ID
- NCT01348321
- Acronym / sponsor ID
- Acne and levamisole
- Conditions
- Acne
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Ahvaz Jundishapur University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 5 May 2011 (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.
Different immunologic mechanisms contribute to development of inflammation in acne vulgaris and immunologic effect of levamisole has been demonstrated.
Objective: The aim of this study was to compare azithromycin and levamisole with azithromycin alone in the treatment of acne vulgaris.
Detailed description
An investigator blind clinical randomized prospective two months study was designed. One hundred sixty nine acne patients presenting in our outpatients clinic were randomly allocated to two treatment groups: azithromycin and levamisole ( group 1 ) and azithromycin alone ( group 2 ) .One hundred forty eight patients completed the duration of the study and their clinical responses were evaluated and compared by using monthly photographic records .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromicine plus levamisole | Experimental | Drug: Levamisole |
| Azithromicin | Experimental | Drug: Levamisole |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who had at least 20 papules and/or pustules,
- Patients with nodule and/or cyst disregarding the number of papules of pustules, were included the study. There was not any age limit
Key exclusion criteria (5 listed)
- were using any type of systemic treatment for their acne at the time of visit or during the last month;
- had any hematological, renal or hepatic disease
- were pregnant or lactating;
- had drug-induced acne;
- were using alcohol, anti-convulsants or anti-coagulants.
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 |
|---|---|---|
| LevamisoleGroup 1: Azithromycin 500 mg per day, three days a week plus oral levamisole 150 mg per day, two days a week. Group 2: Azithromycin 500 mg per day, three days a week. The used medications were not revealed to their physician. A questionnaire was filled for every patient and photos were taken from lesions using a digital camera at first, second and final visit. | Drug | Azithromicin, Azithromicine plus levamisole |
Primary outcome
Number of Participants with Adverse Events
Time frame: one year
A questionnaire was filled for every patient.For patients in both groups, lab tests were done at each visit.All adverse effect and the number of them were recorded and the patients who had side-effects or didn't follow the visits were excluded from the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
- Background: PubMed 6457452Haneke E. [Levamisole treatment of acne fulminans (author's transl)]. Z Hautkr. 1981 Sep 1;56(17):1160-6. German.
- Results publication: PubMed 18720689Ansarin H, Savabynasab S, Behzadi AH, Sadigh N, Hasanloo J. Doxycycline plus levamisole: combination treatment for severe nodulocystic acne. J Drugs Dermatol. 2008 Aug;7(8):737-40.
- Derived from this study: PubMed 23547851Rassai S, Mehri M, Yaghoobi R, Sina N, Mohebbipour A, Feily A. Superior efficacy of azithromycin and levamisole vs. azithromycin in the treatment of inflammatory acne vulgaris: an investigator blind randomized clinical trial on 169 patients. Int J Clin Pharmacol Ther. 2013 Jun;51(6):490-4. doi: 10.5414/CP201861.
Related trials for Acne
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Sima Rasaii, Dermtologist principal investigator
Jundishapur University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Levamisole in people with Acne, run by Ahvaz Jundishapur 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 5 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: finished, as of the sponsor's last update on 5 May 2011. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348321, which also lists 3 linked publications.
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 5 May 2011.