Hidradenitis SuppurativaPhase 2NCT00722800
A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS
A Phase 2 study testing drospirenone and ethinyl estradiol (YAZ) in people with Hidradenitis Suppurativa, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and effective for treating hidradenitis suppurativa. Hidradenitis suppurativa (HS) is a chronic (long lasting) skin disorder that mostly affects the armpits and groin area. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- drospirenone and ethinyl estradiol (YAZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female Subjects 14-45 years of age who have achieved spontaneous menarche.
- Clinical diagnosis of hidradenitis suppurativa of stage II or greater on the Hurley scale.
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures.
Who cannot join
- Change is use of oral or topical antibiotics in past 90 days.
- Use of intralesional steroids within 30 days.
- Use of isotretinoin in past six months.
- Use of biologics such as Infliximab (Remicade®) or Etanercept (Enbrel®) within the past 3 months or 5 half lives (whichever is shorter).
- History of renal insufficiency
- History of hepatic dysfunction
Show all 22Show fewer
- History of adrenal Insufficiency
- History of vascular or metabolic disease including existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition which could increase the risk to suffer any of the above mentioned disorders
- History of hypertension
- History of Diabetes mellitus with vascular involvement
- Migraine headaches with focal neurological symptoms
- Major surgery with prolonged immobilization
- Known or suspected carcinoma of the breast
- History of Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- History of Liver tumor (benign or malignant) or active liver disease
- Smokers
- Regular intake of medications that may increase potassium levels such as NSAIDS, potassium sparing diuretics, potassium supplementation, ACE inhibitors, Angiotensin-II receptor antagonists, heparin and aldosterone antagonists.
- Hypersensitivity to any component of the study drug
- Clinically significant abnormal findings or conditions (other than acne), which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
- Subjects who are known to be pregnant or planning a pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Unit for Research Trials in Skin
Boston, Massachusetts, 02114
About this study
Official title: A Single-Center, Randomized Double-Blind, Parallel-Group Study to Examine the Safety and Efficacy of YAZ Compared With Placebo In The Treatment Of Hidradenitis Suppurativa
The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and effective for treating hidradenitis suppurativa. Hidradenitis suppurativa (HS) is a chronic (long lasting) skin disorder that mostly affects the armpits and groin area. It appears as blackheads and one or more red, tender bumps that may enlarge, break open, and drain pus. Scarring may result after several attacks of the disease.
The exact cause of HS isn't known. However, it is believed that the plugging of hair follicles and bacterial infection that occur in acne also occur in HS. Many of the medications used for treating acne are also used for HS. However, none of the medications are consistently effective.
Read more
YAZ is a combination birth control pill. Nearly all birth control pills are made up of a combination of estrogen and progestin hormones. YAZ contains ethinyl estradiol (an estrogen) and drospirenone (a progestin). People who develop acne have sebaceous glands that are over-stimulated by male sex hormones (androgens). Sebaceous glands secrete an oily substance into a hair follicle to lubricate hair or skin. The progestin in YAZ actually blocks the male sex hormones (androgens) that cause acne. Hormones seem to play a role in HS as the condition occurs after puberty. It affects more women than men and HS often gets worse around the time a women has her menstrual period.
YAZ has been approved by the U.S. Food and Drug Administration (FDA) to treat moderate acne in women who desire an oral contraceptive for birth control.
This study uses a placebo. A placebo looks like the study drug but contains no active drug. We use placebos in research studies to learn if the effects seen in research subjects are truly from the study drug or from other reasons.
Read the detailed description
Hidradenitis suppurativa is a chronic suppurative and scarring disease primarily affecting the axillae and inguinal and perineal areas. The apocrine glands are the primary targets. It is characterized by firm, tender red nodules that soon become fluctuant and painful. Rupture of the lesion, suppuration, formation of sinus tracts and scarring may occur.
The exact etiology of HS remains obscure. Proposed etiologic factors include follicular occlusion and bacterial infection, genetics, host defense defects, hormones, cigarette smoking, and irritants. Hormones seem to play a role, as the condition occurs after puberty, affects more women than men, and often flares in the perimenstrual period.
Treating hidradenitis remains a challenge. Although many patients benefit from long-term treatment with systemic antibiotics (eg, tetracycline, minocycline, clindamycin, erythromycin in combination with metronidazole), no published evidence suggests that the long-term use of antibiotics alters the natural course of HS. Oral isotretinoin has been used, but is effective only in some cases. Some patients have had a beneficial response to biological agents, especially anti-TNF alpha biologicals such as infliximab. Oral contraceptives containing norgestrel or cyproterone acetate, alone or in combination with supplemental cyproterone acetate, spironolactone or dexamethasone (to block adrenal androgen production), have been shown to reduce the frequency and severity of attacks in women.
YAZ is an oral contraceptive that is FDA approved for acne vulgaris. Unlike other progestins, drospirenone has unique antimineralocorticoid (mild diuretic effect) and antiandrogenic properties. The antiandrogenic property of drospirenone means that it blocks the male sex hormones that can cause acne. It is hoped that that YAZ will offer patients with hidradenitis suppurativa a safe and effective therapeutic option.
Subjects will be assigned to a treatment group upon randomization. Bayer HealthCare Pharmaceuticals personnel, investigators, subjects and study nurse/coordinators will be blinded to the study product treatment assignment. The study duration will be 24 weeks with visits at screening, baseline (week 0), week 6, week 12, week 18, and week 24. Lesion counts (total, inflammatory, non-inflammatory) and an ISGA, and photography will be performed on every visit. A physical examination will be done at baseline and Week 24. Safety will be assessed from reported adverse events (AEs).
- Conditions
- Hidradenitis Suppurativa
- Being tested
- drospirenone and ethinyl estradiol (YAZ), Placebo
- Keywords
- YAZ, oral contraceptive, hidradenitis suppurativa
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drospirenone and ethinyl estradiol (YAZ)Drug
1 tablet daily for 24 weeks
PlaceboDrug
1 tablet daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | drospirenone and ethinyl estradiol Receives: Drug: drospirenone and ethinyl estradiol (YAZ) |
| B | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Improvement in the Sartorius Severity Score at Month 6.
The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
Measured: 6 months
Secondary outcomes (2)
Change From Baseline in VAS Pain Scale at Month 6.
For this pain assessment, the participant indicated the level of average pain experienced over the past 24 hours on a horizontal line, 10 cm in length. A score of 0 indicated "no pain" and a score of 10 indicated "worst pain". The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity.
Measured: 6 months from Baseline
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.
Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Alexandra Kimball, Massachusetts General Hospital
- Investigators
- Alexandra B Kimball, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722800
- Sponsor's protocol ID
- 20080p-000843
- Status last verified
- Jan 2014
- First submitted
- 24 Jul 2008
- Last updated
- 10 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized Double-Blind, Parallel-Group Study to Examine the Safety and Efficacy of YAZ Compared With Placebo In The Treatment Of Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT00722800
- Acronym / sponsor ID
- 20080p-000843
- Conditions
- Hidradenitis Suppurativa
- Keywords
- YAZ, oral contraceptive, hidradenitis suppurativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Posted 16 Jan 2014
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 study is to find out if taking a birth control pill, YAZ, is safe and effective for treating hidradenitis suppurativa. Hidradenitis suppurativa (HS) is a chronic (long lasting) skin disorder that mostly affects the armpits and groin area. It appears as blackheads and one or more red, tender bumps that may enlarge, break open, and drain pus. Scarring may result after several attacks of the disease.
The exact cause of HS isn't known. However, it is believed that the plugging of hair follicles and bacterial infection that occur in acne also occur in HS. Many of the medications used for treating acne are also used for HS. However, none of the medications are consistently effective.
YAZ is a combination birth control pill. Nearly all birth control pills are made up of a combination of estrogen and progestin hormones. YAZ contains ethinyl estradiol (an estrogen) and drospirenone (a progestin). People who develop acne have sebaceous glands that are over-stimulated by male sex hormones (androgens). Sebaceous glands secrete an oily substance into a hair follicle to lubricate hair or skin. The progestin in YAZ actually blocks the male sex hormones (androgens) that cause acne. Hormones seem to play a role in HS as the condition occurs after puberty. It affects more women than men and HS often gets worse around the time a women has her menstrual period.
YAZ has been approved by the U.S. Food and Drug Administration (FDA) to treat moderate acne in women who desire an oral contraceptive for birth control.
This study uses a placebo. A placebo looks like the study drug but contains no active drug. We use placebos in research studies to learn if the effects seen in research subjects are truly from the study drug or from other reasons.
Detailed description
Hidradenitis suppurativa is a chronic suppurative and scarring disease primarily affecting the axillae and inguinal and perineal areas. The apocrine glands are the primary targets. It is characterized by firm, tender red nodules that soon become fluctuant and painful. Rupture of the lesion, suppuration, formation of sinus tracts and scarring may occur.
The exact etiology of HS remains obscure. Proposed etiologic factors include follicular occlusion and bacterial infection, genetics, host defense defects, hormones, cigarette smoking, and irritants. Hormones seem to play a role, as the condition occurs after puberty, affects more women than men, and often flares in the perimenstrual period.
Treating hidradenitis remains a challenge. Although many patients benefit from long-term treatment with systemic antibiotics (eg, tetracycline, minocycline, clindamycin, erythromycin in combination with metronidazole), no published evidence suggests that the long-term use of antibiotics alters the natural course of HS. Oral isotretinoin has been used, but is effective only in some cases. Some patients have had a beneficial response to biological agents, especially anti-TNF alpha biologicals such as infliximab. Oral contraceptives containing norgestrel or cyproterone acetate, alone or in combination with supplemental cyproterone acetate, spironolactone or dexamethasone (to block adrenal androgen production), have been shown to reduce the frequency and severity of attacks in women.
YAZ is an oral contraceptive that is FDA approved for acne vulgaris. Unlike other progestins, drospirenone has unique antimineralocorticoid (mild diuretic effect) and antiandrogenic properties. The antiandrogenic property of drospirenone means that it blocks the male sex hormones that can cause acne. It is hoped that that YAZ will offer patients with hidradenitis suppurativa a safe and effective therapeutic option.
Subjects will be assigned to a treatment group upon randomization. Bayer HealthCare Pharmaceuticals personnel, investigators, subjects and study nurse/coordinators will be blinded to the study product treatment assignment. The study duration will be 24 weeks with visits at screening, baseline (week 0), week 6, week 12, week 18, and week 24. Lesion counts (total, inflammatory, non-inflammatory) and an ISGA, and photography will be performed on every visit. A physical examination will be done at baseline and Week 24. Safety will be assessed from reported adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: drospirenone and ethinyl estradiol (YAZ)drospirenone and ethinyl estradiol |
| B | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female Subjects 14-45 years of age who have achieved spontaneous menarche.
- Clinical diagnosis of hidradenitis suppurativa of stage II or greater on the Hurley scale.
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures.
Key exclusion criteria (22 listed)
- Change is use of oral or topical antibiotics in past 90 days.
- Use of intralesional steroids within 30 days.
- Use of isotretinoin in past six months.
- Use of biologics such as Infliximab (Remicade®) or Etanercept (Enbrel®) within the past 3 months or 5 half lives (whichever is shorter).
- History of renal insufficiency
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 |
|---|---|---|
| drospirenone and ethinyl estradiol (YAZ)1 tablet daily for 24 weeks | Drug | A |
| Placebo1 tablet daily for 24 weeks | Drug | B |
Primary outcome
Mean Improvement in the Sartorius Severity Score at Month 6.
Time frame: 6 months
The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
2 secondary outcomes
Change From Baseline in VAS Pain Scale at Month 6.
Time frame: 6 months from Baseline
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
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Acceptability of MBSR for People With HS
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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
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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.
Alexandra B Kimball, MD, MPH principal investigator
Massachusetts General Hospital
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 drospirenone and ethinyl estradiol (YAZ) in people with Hidradenitis Suppurativa, run by Massachusetts General Hospital 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 4 inclusion and 22 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: stopped early, as of the sponsor's last update on 10 Feb 2014. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Improvement in the Sartorius Severity Score at Month 6. (time frame: 6 months). 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 10 Feb 2014.