Acne VulgarisPhase 1/2NCT00361322
Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris
A Phase 1/2 study testing clindamycin phosphate and salicylic acid in people with Acne Vulgaris, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The concept behind our study was to combine an effect of antibiotic and anti-inflammatory agents for a more efficient acne therapy directed at the factors involved in the pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin phosphate and salicylic acid in a non-irritating carrier. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- clindamycin phosphate and salicylic acid
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2005to Jan 2006
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- Adult
Who may be able to join
- mild to moderate acne vulgaris;
- at least 5 lesions on the face;
- a one-month wash-out period was established for any topical or systemic drug use for treatment of acne vulgaris.
Who cannot join
- acne that was primarily truncal, nodular, or due to secondary causes/internal disease;
- pregnancy, breastfeeding, or intention to become pregnant;
- another dermatological disease of the face;
- significant systemic disease;
- any drug/alcohol addiction;
- interacting medication;
- known hypersensitivity to study medications;
- history of chronic disease treated with medications which might affect acne condition and treatment outcome (e.g. corticosteroids, lithium, isoniazid, anti-androgens, phenytoin, phenobarbital) in the preceding month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris
The concept behind our study was to combine an effect of antibiotic and anti-inflammatory agents for a more efficient acne therapy directed at the factors involved in the pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin phosphate and salicylic acid in a non-irritating carrier.
- Conditions
- Acne Vulgaris
- Being tested
- clindamycin phosphate, salicylic acid
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clindamycin phosphateDrug
salicylic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesions count at the baseline (week 0)
Lesions count at the end of study (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startApr 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Vera Leibovici, MD, Principal investigator, Hadassah Medical OrganizationArie Ingber, MD, Prof, Principal investigator, Hadassah Medical OrganizationElka Touitou, PhD, Prof, Principal investigator, The Hebrew University of Jerusalem, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361322
- Sponsor's protocol ID
- CLSA-HMO-CTIL
- Status last verified
- Aug 2006
- First submitted
- 6 Aug 2006
- Last updated
- 8 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00361322
- Acronym / sponsor ID
- CLSA-HMO-CTIL
- Conditions
- Acne Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Jan 2006
- First posted
- 8 Aug 2006 (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.
The concept behind our study was to combine an effect of antibiotic and anti-inflammatory agents for a more efficient acne therapy directed at the factors involved in the pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin phosphate and salicylic acid in a non-irritating carrier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (3 listed)
- mild to moderate acne vulgaris;
- at least 5 lesions on the face;
- a one-month wash-out period was established for any topical or systemic drug use for treatment of acne vulgaris.
Key exclusion criteria (8 listed)
- acne that was primarily truncal, nodular, or due to secondary causes/internal disease;
- pregnancy, breastfeeding, or intention to become pregnant;
- another dermatological disease of the face;
- significant systemic disease;
- any drug/alcohol addiction;
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 |
|---|---|---|
| clindamycin phosphate | Drug | – |
| salicylic acid | Drug | – |
Primary outcome
Lesions count at the baseline (week 0)
Lesions count at the end of study (week 8)
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 8 Aug 2006.
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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.
Vera Leibovici, MD principal investigator
Hadassah Medical Organization
Arie Ingber, MD, Prof principal investigator
Hadassah Medical Organization
Elka Touitou, PhD, Prof principal investigator
The Hebrew University of Jerusalem, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing clindamycin phosphate and salicylic acid in people with Acne Vulgaris, run by Hadassah Medical Organization at 1 site in Israel.
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 3 inclusion and 8 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 8 Aug 2006. 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 Israel. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Lesions count at the baseline (week 0). The study lists 2 primary outcomes in all. 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 8 Aug 2006.