Hidradenitis SuppurativaNCT01063270
Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa
A study testing Clindamycin & Rifampin and Clindamycin + Rifampin along with NdYag Laser treatment in people with Hidradenitis Suppurativa, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this research study is to further evaluate the efficacy of two treatment regimens for the treatment of hidradenitis suppurativa. This is a randomized controlled study. Patients will be randomly assigned to an arm of the study. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Clindamycin & Rifampin and Clindamycin + Rifampin along with NdYag Laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2013
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be at least 16 years old and weigh a minimum of 80lbs. Weight requirement is for the purpose of maintaining safe clindamycin and rifampin dosing regimens.
- Be otherwise healthy
- Have a diagnosis of HS
- Patients must have Hurley stage II HS, with one or more widely separated recurrent abscesses, with tract and scarring. Involvement should be bilateral and symmetric on axillae, inguinal regions or inframammary regions
- Agree to abide by the Investigator's guidelines regarding photosensitizing drugs
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- Agree to follow and undergo all study-related procedures
Who cannot join
- Patients with HS Hurley stage I and III will be excluded from participation in the study
- Patients who are currently pregnant will not be able to take part in the study due to the unknown effects of antibiotics
- Concomitant use of systemic or topical treatments for HS not involved in current study. Patients must discontinue all forms of oral therapy as systemic and topical antibiotics and retinoids for 2 weeks prior to the start of any treatment
- Exacerbation of the patient's original condition expressed clinically by a shift from Hurley Stage II to Stage III
- Patient is unable to take antibiotic therapy
- Any reason the investigator feels the patient should not participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Hospital Department of Dermatology. 3031 West Grand Blvd, Suite 800
Detroit, Michigan, 48202
About this study
Official title: Randomized Control Trial Comparing Efficacy of Antibiotic Therapy Alone Versus Antibiotic Therapy in Conjunction With Quadruple Pulse Therapy Using NdYag Laser in Treatment of Hidradenitis Suppurativa
The purpose of this research study is to further evaluate the efficacy of two treatment regimens for the treatment of hidradenitis suppurativa. This is a randomized controlled study. Patients will be randomly assigned to an arm of the study.
Read the detailed description
Histological studies suggest that HS is a disease of the follicles with apocrine involvement as a secondary event. The investigators have identified in a previous study that the Nd Yag laser is highly effective for decreasing the inflammation, pain, suppuration and frequency of recurrence of HS. Oral antibiotic therapy with Clindamycin and Rifampin has also been reported in previous studies to be a highly effective treatment regimen for HS and is commonly used by physicians in medical management of HS. The investigators would like to compare the efficacy of NdYag laser treatment combined with antibiotics versus treatment with antibiotics alone. The goal is to evaluate the success of these two treatment regimens on existent HS lesions as well as prevention of recurrence. There will be approximately 18 people in this research study at Henry Ford Health System (HFHS).
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Clindamycin & Rifampin, Clindamycin + Rifampin along with NdYag Laser treatment
- Keywords
- Hidradenitis Suppurativa, Antibiotics, Laser
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin & RifampinDrug
Clindamycin 300mg twice daily for 10 weeks and Rifampin 300mg twice daily for 10 weeks
Clindamycin + Rifampin along with NdYag Laser treatmentProcedure or surgery
Clindamycin 300mg twice daily for 2 weeks Rifampin 300mg twice daily for 2 weeks along with 3 NdYag laser sessions.
| Study group | Role | What they receive |
|---|---|---|
| Oral Antibiotics | Active comparator | Not described Receives: Drug: Clindamycin & Rifampin |
| Topical Antibiotics and Laser treatment | Active comparator | Not described Receives: Procedure: Clindamycin + Rifampin along with NdYag Laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of lesions
Measured: 5 total clinic visits over 6 month period
Secondary outcomes (2)
Change in quality of life during treatment
Measured: 5 total clinic visits over 6 month period
Recurrence of disease
Measured: 5 total clinic visits over 6 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat Hamzavi, M.D., Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063270
- Sponsor's protocol ID
- IRB5974
- Status last verified
- Jul 2022
- First submitted
- 2 Feb 2010
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Comparing Efficacy of Antibiotic Therapy Alone Versus Antibiotic Therapy in Conjunction With Quadruple Pulse Therapy Using NdYag Laser in Treatment of Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT01063270
- Acronym / sponsor ID
- IRB5974
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Antibiotics, Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Feb 2010 (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 purpose of this research study is to further evaluate the efficacy of two treatment regimens for the treatment of hidradenitis suppurativa. This is a randomized controlled study. Patients will be randomly assigned to an arm of the study.
Detailed description
Histological studies suggest that HS is a disease of the follicles with apocrine involvement as a secondary event. The investigators have identified in a previous study that the Nd Yag laser is highly effective for decreasing the inflammation, pain, suppuration and frequency of recurrence of HS. Oral antibiotic therapy with Clindamycin and Rifampin has also been reported in previous studies to be a highly effective treatment regimen for HS and is commonly used by physicians in medical management of HS. The investigators would like to compare the efficacy of NdYag laser treatment combined with antibiotics versus treatment with antibiotics alone. The goal is to evaluate the success of these two treatment regimens on existent HS lesions as well as prevention of recurrence. There will be approximately 18 people in this research study at Henry Ford Health System (HFHS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Antibiotics | Active comparator | Drug: Clindamycin & Rifampin |
| Topical Antibiotics and Laser treatment | Active comparator | Procedure: Clindamycin + Rifampin along with NdYag Laser treatment |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 16 years old and weigh a minimum of 80lbs. Weight requirement is for the purpose of maintaining safe clindamycin and rifampin dosing regimens.
- Be otherwise healthy
- Have a diagnosis of HS
- Patients must have Hurley stage II HS, with one or more widely separated recurrent abscesses, with tract and scarring. Involvement should be bilateral and symmetric on axillae, inguinal regions or inframammary regions
- Agree to abide by the Investigator's guidelines regarding photosensitizing drugs
Key exclusion criteria (6 listed)
- Patients with HS Hurley stage I and III will be excluded from participation in the study
- Patients who are currently pregnant will not be able to take part in the study due to the unknown effects of antibiotics
- Concomitant use of systemic or topical treatments for HS not involved in current study. Patients must discontinue all forms of oral therapy as systemic and topical antibiotics and retinoids for 2 weeks prior to the start of any treatment
- Exacerbation of the patient's original condition expressed clinically by a shift from Hurley Stage II to Stage III
- Patient is unable to take antibiotic therapy
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 & RifampinClindamycin 300mg twice daily for 10 weeks and Rifampin 300mg twice daily for 10 weeks | Drug | Oral Antibiotics |
| Clindamycin + Rifampin along with NdYag Laser treatmentClindamycin 300mg twice daily for 2 weeks Rifampin 300mg twice daily for 2 weeks along with 3 NdYag laser sessions. | Procedure or surgery | Topical Antibiotics and Laser treatment |
Primary outcome
Number and severity of lesions
Time frame: 5 total clinic visits over 6 month period
2 secondary outcomes
Change in quality of life during treatment
Time frame: 5 total clinic visits over 6 month period
Recurrence of disease
Time frame: 5 total clinic visits over 6 month period
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 22 Jul 2022.
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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.
Iltefat Hamzavi, M.D. principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clindamycin & Rifampin and Clindamycin + Rifampin along with NdYag Laser treatment in people with Hidradenitis Suppurativa, run by Henry Ford Health System at 1 site in United States.
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 7 inclusion and 6 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 22 Jul 2022. 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 United States. 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.
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 and severity of lesions (time frame: 5 total clinic visits over 6 month period). 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 22 Jul 2022.