Acne VulgarisPhase 3NCT00722761
Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne
A Phase 3 study testing drospirenone and ethinyl estradiol in people with Acne Vulgaris, 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 acne on the trunk (the main part of the body that does not include the arms, legs, and head). Acne vulgaris is a very common skin disorder. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- drospirenone and ethinyl estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2012
- Phase
- Phase 3
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female Subjects 18-45 years of age who have achieved spontaneous menarche.
- A clinical diagnosis of truncal acne vulgaris and the desire for an oral contraceptive for birth control.
- A minimum of 10 but not more than 50 inflammatory lesions on the back and chest combined.
- Maximum of 5 nodules.
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures.
Who cannot join
- Use of topical acne medications such as tretinoin, benzoyl peroxide or topical antibiotics within 2 weeks
- Use of oral antibiotics within 30 days.
- Use of systemic corticosteroids within 4 weeks.
- Use of oral contraceptives within 12 weeks.
- Use of isotretinoin in past six months.
- Use of phototherapy devices for acne such as ClearLight or Zenozapper within 1 week.
Show all 26Show fewer
- Use of tanning booths or lamps within 1 week prior to baseline.
- BMI >30
- History of renal insufficiency
- History of hepatic dysfunction
- 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
- Diabetes mellitus with vascular involvement
- Migraine headaches with focal neurological symptoms
- Recent major surgery with prolonged immobilization
- Known or suspected carcinoma of the breast
- 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
- Liver tumor (benign or malignant) or active liver disease
- Smoking > ½ pack of cigarettes/week
- 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 Moderate Truncal Acne Vulgaris
The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and effective for treating acne on the trunk (the main part of the body that does not include the arms, legs, and head).
Acne vulgaris is a very common skin disorder. It is caused when oil-producing skin glands (sebaceous glands) become plugged. The plug can cause blackheads, whiteheads, pimples, and cysts on the face, neck, upper chest, and upper back.
Read more
YAZ is a combination birth control pill. A "combination" pill means that it is made up of more than one major ingredient. Nearly all birth control pills are made up of a combination of estrogen and progestin hormones. Estrogens are steroid hormones produced by the ovaries responsible for the typical female features. Progestins are steroid hormones produced by the ovary and placenta responsible for making the uterus fit for pregnancy. YAZ also contains an estrogen called ethinyl estradiol, and a progestin called drospirenone. People who develop acne have sebaceous glands that are over-stimulated (that is, the sebaceous glands have increased activity) by male sex hormones (androgens). The progestin in YAZ blocks the male sex hormones (androgens) that cause acne.
The study drug being used in this study is called YAZ. It has been approved by the U.S. Food and Drug Administration (FDA) to treat moderate acne in women who want an oral contraceptive for birth control.
In this study, YAZ will be compared to a placebo for safety and effectiveness. A placebo looks like the study drug but contains no active drug (like a sugar pill). 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
Acne is a common skin disease that affects 85-100% of the population. Although it often appears during puberty, it may persist during the third decade of life and even later. It is characterized by a variety of lesions consisting of non-inflammatory lesions known as comedones, and inflammatory lesions such as papules, pustules, nodules and cysts. It commonly occurs on the face, chest, and back. Although not as noticeable as facial acne, truncal acne may also affect a person's self esteem and body image and reduce one's participation in sports because of the need to undress in a shared locker room. Most acne studies focus on facial acne and ignore treatment outcomes in the chest and back.
The pathogenesis of acne is multifactorial, developing in the sebaceous gland. These factors include intrafollicular hypercornification, which induces follicular obstruction resulting in comedone formation, excess sebum production, Propionibacterium acnes activity and inflammation.
Hormone therapies, such as oral contraceptives and antiandrogens (e.g. spironolactone) counteract the effects of androgens on the sebaceous glands. It has been over ten years since estrogen-containing oral contraceptives (OCs) first obtained FDA approval for use in acne. Since then, several randomized controlled trials have corroborated their efficacy and safety for this growing indication in women of child bearing age. Studies have shown hormonal therapies to be effective in treating moderate acne vulgaris in women with no known contraindication to OC therapy.
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. In two multicenter, double blind, randomized, placebo-controlled studies, 889 subjects, ages 14 to 45 years, with moderate acne received YAZ or placebo for six 28 day cycles. The primary efficacy endpoints were the percent change in inflammatory lesions, non-inflammatory lesions, total lesions, and the percentage of subjects with a "clear" or "almost clear" rating on the Investigator's Static Global Assessment (ISGA) scale on day 15 of cycle 6.
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
- Acne Vulgaris
- Being tested
- drospirenone and ethinyl estradiol, Placebo tablet
- Keywords
- YAZ, oral contraceptive, Acne vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drospirenone and ethinyl estradiolDrug
Also called YAZ
Drosperinone (3mg) and ethinyl estradiol (0.02mg) tablet given once daily for 24 weeks
Placebo tabletDrug
Also called Placebo
Placebo tablet (no active drug) given once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Drosperinone and Ethinyl estradiol | Active comparator | Drospirenone and Ethinyl estradiol (3mg/0.02mg)(YAZ)tablet once a day Receives: Drug: drospirenone and ethinyl estradiol |
| Placebo tablet | Placebo comparator | Placebo tablet once a day Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Truncal Lesion Counts
Acne lesion count (noninflammatory, inflammatory and total lesions) difference between week 0 (baseline) and week 24 is divided by the acne lesion count at week 0 and multiplied by 100. A positive change indicates a decrease in truncal acne lesions.
Measured: 0-24 weeks
Secondary outcomes (1)
Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination
Percentage of subjects rated Clear (score 0) or Almost Clear (score 1) on the Investigator's Global Assessment (IGA) of truncal acne at Week 24 as well as Subject's Assessment of Acne at Week 24/Early Termination were taken. It was computed by: number of successes (those scored 0 or 1)divided by the number of participants multiplied by 100.
Measured: 24 weeks
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 startApr 2009
- Primary completionApr 2012
- Study completionApr 2012
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 Acne VulgarisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT00722761
- Sponsor's protocol ID
- 2008-P-000754
- Status last verified
- Jan 2013
- First submitted
- 24 Jul 2008
- Last updated
- 5 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. 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 Moderate Truncal Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00722761
- Acronym / sponsor ID
- 2008-P-000754
- Conditions
- Acne Vulgaris
- Keywords
- YAZ, oral contraceptive, Acne vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Apr 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Posted 5 Mar 2013
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 acne on the trunk (the main part of the body that does not include the arms, legs, and head).
Acne vulgaris is a very common skin disorder. It is caused when oil-producing skin glands (sebaceous glands) become plugged. The plug can cause blackheads, whiteheads, pimples, and cysts on the face, neck, upper chest, and upper back.
YAZ is a combination birth control pill. A "combination" pill means that it is made up of more than one major ingredient. Nearly all birth control pills are made up of a combination of estrogen and progestin hormones. Estrogens are steroid hormones produced by the ovaries responsible for the typical female features. Progestins are steroid hormones produced by the ovary and placenta responsible for making the uterus fit for pregnancy. YAZ also contains an estrogen called ethinyl estradiol, and a progestin called drospirenone. People who develop acne have sebaceous glands that are over-stimulated (that is, the sebaceous glands have increased activity) by male sex hormones (androgens). The progestin in YAZ blocks the male sex hormones (androgens) that cause acne.
The study drug being used in this study is called YAZ. It has been approved by the U.S. Food and Drug Administration (FDA) to treat moderate acne in women who want an oral contraceptive for birth control.
In this study, YAZ will be compared to a placebo for safety and effectiveness. A placebo looks like the study drug but contains no active drug (like a sugar pill). 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
Acne is a common skin disease that affects 85-100% of the population. Although it often appears during puberty, it may persist during the third decade of life and even later. It is characterized by a variety of lesions consisting of non-inflammatory lesions known as comedones, and inflammatory lesions such as papules, pustules, nodules and cysts. It commonly occurs on the face, chest, and back. Although not as noticeable as facial acne, truncal acne may also affect a person's self esteem and body image and reduce one's participation in sports because of the need to undress in a shared locker room. Most acne studies focus on facial acne and ignore treatment outcomes in the chest and back.
The pathogenesis of acne is multifactorial, developing in the sebaceous gland. These factors include intrafollicular hypercornification, which induces follicular obstruction resulting in comedone formation, excess sebum production, Propionibacterium acnes activity and inflammation.
Hormone therapies, such as oral contraceptives and antiandrogens (e.g. spironolactone) counteract the effects of androgens on the sebaceous glands. It has been over ten years since estrogen-containing oral contraceptives (OCs) first obtained FDA approval for use in acne. Since then, several randomized controlled trials have corroborated their efficacy and safety for this growing indication in women of child bearing age. Studies have shown hormonal therapies to be effective in treating moderate acne vulgaris in women with no known contraindication to OC therapy.
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. In two multicenter, double blind, randomized, placebo-controlled studies, 889 subjects, ages 14 to 45 years, with moderate acne received YAZ or placebo for six 28 day cycles. The primary efficacy endpoints were the percent change in inflammatory lesions, non-inflammatory lesions, total lesions, and the percentage of subjects with a "clear" or "almost clear" rating on the Investigator's Static Global Assessment (ISGA) scale on day 15 of cycle 6.
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 |
|---|---|---|
| Drosperinone and Ethinyl estradiol | Active comparator | Drug: drospirenone and ethinyl estradiolDrospirenone and Ethinyl estradiol (3mg/0.02mg)(YAZ)tablet once a day |
| Placebo tablet | Placebo comparator | Drug: Placebo tabletPlacebo tablet once a day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female Subjects 18-45 years of age who have achieved spontaneous menarche.
- A clinical diagnosis of truncal acne vulgaris and the desire for an oral contraceptive for birth control.
- A minimum of 10 but not more than 50 inflammatory lesions on the back and chest combined.
- Maximum of 5 nodules.
- Willing and able to understand and sign informed consent.
Key exclusion criteria (26 listed)
- Use of topical acne medications such as tretinoin, benzoyl peroxide or topical antibiotics within 2 weeks
- Use of oral antibiotics within 30 days.
- Use of systemic corticosteroids within 4 weeks.
- Use of oral contraceptives within 12 weeks.
- Use of isotretinoin in past six 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 |
|---|---|---|
| drospirenone and ethinyl estradiolAlso: YAZDrosperinone (3mg) and ethinyl estradiol (0.02mg) tablet given once daily for 24 weeks | Drug | Drosperinone and Ethinyl estradiol |
| Placebo tabletAlso: PlaceboPlacebo tablet (no active drug) given once daily for 24 weeks | Drug | Placebo tablet |
Primary outcome
Percent Change in Truncal Lesion Counts
Time frame: 0-24 weeks
Acne lesion count (noninflammatory, inflammatory and total lesions) difference between week 0 (baseline) and week 24 is divided by the acne lesion count at week 0 and multiplied by 100. A positive change indicates a decrease in truncal acne lesions.
1 secondary outcome
Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 3 study testing drospirenone and ethinyl estradiol in people with Acne Vulgaris, 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 6 inclusion and 26 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 Mar 2013. 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 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?
Yes. Results are posted in the registry (first posted 5 Mar 2013). 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?
Percent Change in Truncal Lesion Counts (time frame: 0-24 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 5 Mar 2013.