Frequency Of And Plans For Trial Conduct Auditing
An inspection or audit may take place as part of this study, performed by the Sponsor and/or by the regulatory authorities. Inspectors will check the documents, logistics, records and any other resources that the authorities consider to be associated with the clinical trial and that may be located at the trial site itself.
How Aldactone Is Used
Unlike most acne treatments, Aldactone isn’t applied to the skin. Instead, it’s taken orally. When Aldactone is used as an acne treatment, the most common dosage is between 50 and 100 milligrams daily.
Your dermatologist may start you on a lower dose. It is common to start at 25 mg daily and work up to a target dose over several weeks. Your healthcare provider will base the dosage on your personal situation.
If your breakouts only happen around the time of your menstrual cycle, you may only need Aldactone during the week before your period. This can help even out the hormone spikes that trigger acne.
Aldactone is often prescribed with oral contraceptives, or birth control pills. You will probably keep using topical acne medications while using Aldactone. It tends to work best alongside other acne treatments, rather than as the sole treatment.
Plan To Promote Participant Retention And Complete
The patient will be given a diary at the randomization visit, to note their health resource consumption, medical compliance, concomitant treatments and AEs. The visits will be arranged every 2 months up to M6, where the main objective is set. Empty blisters will be collected and counted at each visit. At each visit, the drugs prescribed will be for 2 months . At visit M2 , the physician or a member of their team will have to be vigilant and tell the patient to carefully follow the chronological order of treatments. Two envelopes will be given to the patient, one for M3 and one for M4 . As aforementioned, the guidelines stipulate that treatment with doxycycline should not exceed 3 months. For this reason, patients in the doxycycline arm will be given a placebo during month 4 and the following months .
Recommended Reading: Is Astringent Good For Acne
How Does Spironolactone Work On Acne
Acne is a common skin condition that affects everyone from teens to adults. There are hundreds of different treatments on the market targeting acne. Acne occurs when your hair follicles become clogged with dead skin cells or oil from the skin and manifest in the form of pimples, whiteheads, and blackheads. When typical treatments arent working, doctors may prescribe spironolactone to step in.
Spironolactone works by regulating a hormone called androgen that causes glands in your skin to overproduce oil called sebum. Too much sebum can clog pores and cause acne. Spironolactone works as a synthetic anti-androgen drug, meaning it has properties in common with male hormones and blocks their effects on skin cells. The medication can slow down how fast your body produces androgen, which can slow down acne breakouts.
Your doctor may prescribe oral spironolactone for acne when you have tried other topical treatments and medications. Its best used in combination with other topical treatments and oral contraceptives.
How Long Will I Be On Spironolactone
Spironolactone is not a cure for acne but controls the sensitivity of the sebaceous glands to androgens. Spironolactone is taken for as long as the acne is a problem, which may be for several years. It is usually possible to start lowering the dose one year after the acne has been under excellent control.
Recommended Reading: How To Prevent Acne Before It Starts
Topical Spironolactone Appears To Also Be Moderately Effective In Treating Acne
Spironolactone is almost always prescribed for acne in its oral form but is also available in topical form.
We only have two studies that examine the effectiveness of topical spironolactone for treating acne, but it appears to also be effective. The first, an Italian study, found that one month of treatment with topical spironolactone either cleared or significantly improved acne in the vast majority of patients.14 The second study found that six weeks of treatment with topical spironolactone decreased the number of acne lesions by 71%.15
Expand to read details of studies
A 1990 study in the Italian journal, La Clinica Terapeutica, evaluated the effectiveness of a 5% spironolactone preparation for one month in 20 patients . This study found that acne cleared in 30% of the patients and improved in 65%. The participants did not report side effects.14
A 2012 study in the Journal of Dermatological Treatment compared the effectiveness of a 5% spironolactone gel with that of a placebo. The researchers randomly assigned 78 patients with mild to moderate acne to either a treatment group or a placebo group . Participants applied the medication twice per day for six weeks, leaving the medication on the acne lesions for two to three hours each time before washing it off. After six weeks, the total number of acne lesions in the treatment group decreased by 71%, compared to only 36% in the placebo group.15
Possible Side Effects Of Aldactone
Side effects of low-dose Aldactone aren’t as common as with higher doses. When they do happen, they often include:
- Irregular menstrual cycle
Other side effects can include:
- Thirst or dry mouth
- Stomach cramps, vomiting, and/or diarrhea
- Increased blood potassium levels
- Low blood pressure
Blood pressure should be checked periodically while taking this medication. For some women, blood potassium levels should also be checked. Women younger than 45 years old do not usually need to have potassium levels checked when taking Aldactone.
If Aldactone upsets your stomach, take it with a meal. Because Aldactone acts as a diuretic, it is also important to drink plenty of water.
Recommended Reading: Why Am I Getting Neck Acne
Why Havent You Heard Of Spironolactone For Acne
While dermatologists are increasingly scratching spironolactone onto their Rx pads, many acne sufferers still havent heard of it no matter how many times theyve typed acne and help! into Googles search bar.
Although doctors have known of its skin-clearing effects for the last few decades, the medication is only now gaining recognition as an effective treatment for hormonal acne in women.
The reason spironolactone is still fairly unheard of by acne sufferers is likely due to its main use: treating high blood pressure and heart failure.
While Id taken the birth control pill since I was a teenager in an effort to combat period-induced breakouts, spironolactone works a bit more aggressively. It blocks androgens .
Furthermore, the treatment isnt just targeted for women whose acne flares up around the time of their menstrual cycles. Spironolactone can also help post-menopausal women experiencing a sudden influx of skin issues.
In fact, females with high hormone levels and acne at any age may see improvement with the drug. Men are rarely prescribed spironolactone for acne as it
Are There Concerns About An Increase In The Contraceptive Failure Rate When Using An Oral Antibiotic And An Oral Contraceptive In Combination Especially With Concurrent Use Of Spironolactone
Some women with AV that are refractory to treatment may need to be on a topical regimen along with spironolactone and an oral antibiotic in order to achieve adequate control. The clinician and/or patient may be concerned about the reported decrease in efficacy of an OC when an oral antibiotic is prescribed, since most female patients on spironolactone will often be using some form of birth control, including an OC. There has been some questions about combining an OC with an oral antibiotic, believed to be related to reduction in gut bacterial flora leading to reduced enterohepatic circulation of estrogen. However, there is no definitive evidence to support that oral antibiotics reduce the blood levels of the hormones in OCs or their efficacy. To add, the only antibiotics that have been shown to decrease estrogen levels and reduce contraceptive efficacy are rifamycins, most specifically rifampin, through a different mechanism of induced hepatic metabolism of estrogen. Studies have shown that, overall, there is no difference in the OC failure rate of patients who took OCs with antibiotics compared with those who did not.,
Recommended Reading: How To Get Rid Of Breast Acne Fast
Excess Hair Growth In Women
Oral contraceptives are the initial choice for the treatment of hirsutism, characterized by excess hair growth on the face or body in young women. However, studies have shown that spironolactone added to oral contraceptives delivers better results. When used for hirsutism, 50 200 mg daily in one to two divided doses is better than placebo and better than oral contraceptives alone.
What Side Effects Does Spironolactone Have
Although many people are fine on spironolactone, its important to remember that any medication can come with side effects. Lets take a further look at any potential side effects.
Possible side effects of taking oral spironolactone include:
Going to the bathroom more .
Changes in menstrual cycle .
Breast tenderness and enlargement.
Increased potassium levelsalthough highly unlikely in young patients without underlying medical conditions, its wise to check in periodically with your doctor
Fatigue, headaches, and dizziness.
Birth defects. As a result, spironolactone isnt recommended for pregnant women.
Whereas oral spironolactone shouldnt be taken by cis men, topical spironolactone can be used by everyone. Topical spironolactone has no systemic side-effects, but you may experience some redness, peeling, general irritation in the first few weeks of use.
Read Also: Why Do I Have Back Acne
Answer: 50mg Of Spironolactone Works Well For Hormonal Acne With Little Side Effects
Spironolactone is an excellent medication for treating hormonal acne in females. Unfortunately, at higher doses it can have side effects . I start nearly all of my patients on 50mg daily. Spironolactone takes up to 3 months to have its full effect, at which point I will sometimes decrease the dose or may increase the dose of Spironolactone if necessary. If you are currently taking 50mg daily, that is a great dose for most women with hormonal acne.
Dosage For Heart Failure
If this dose works well for you, your doctor may increase the dosage to 50 mg, once per day.
However, if you develop hyperkalemia , your doctor will likely lower the dosage to 25 mg, every other day. Or they may recommend a medication other than Aldactone.
Also Check: How To Get Rid Of Leg Acne
Does Aldactone Cause Weight Gain
Weight gain wasnt a reported side effect of Aldactone in clinical studies.
However, Aldactone can cause hyperglycemia .* If your blood sugar stays high for a long period of time, it can lead to weight gain.
Symptoms of high blood sugar can include:
If you notice any of the above symptoms, talk with your doctor. If youre taking Aldactone, your doctor can help determine if these are side effects of the drug and advise you on treatment.
* Its not known exactly how often people in clinical trials may have had high blood sugar, but this side effect is rare.
Plans For Communicating Important Protocol Amendments To Relevant Parties
The amended protocol should be a dated, updated version. If necessary, the information form and consent form should be amended. The updated protocol is at version 8 on 26 November 2019. All the submissions/declarations were made by the Sponsor Department at CHU Nantes to the French Regulatory Authority and the southwest Ethical Review Board .
Read Also: Does Differin Help With Acne Scars
How Does Spironolactone Work
Spironolactone works by blocking the action of a hormone called aldosterone, which is used by the body to retain water and sodium.
Aldosterone is produced in the adrenal glands. People with high blood pressure, low potassium levels and other health conditions often have overly high levels of aldosterone. Aldosterone can also contribute to water retention in people with conditions such as kidney failure.
Cosmo Staffers On Their Experience With Spironolactone
I barely gave it a chance. Two months, maybe. My derm required regular blood work while on it, and I didnt want to deal with the time commitment or expense.
KATIE BUCKLEITNER, associate digital art director
Ive been taking it for a few years, and my skin is the clearest its ever been. I still have one or two chin breakouts during my period, but thats so much more manageable than a bunch of zits all over my face.
BRIEHN TRUMBAUER, copy editor
It took a while to notice a true difference, but I love it now! My skin is so much clearer. I was even told to double-dose the week before I start PMSing to help me keep any acne at bay.
MIA LARDIERE, Snapchat editor
I intimately know one of the reasons Spiro is usually prescribed with birth control: It can mess with your periods. I ended up getting my period every eight days for a year, so I had to go off.
CHLOE METZGER, senior beauty editor
Recommended Reading: Why Is My Baby Getting Acne
What Is Spironolactone
Spironolactone is an oral medication that helps clear hormonal acne in women in their 20s and 30s as well as women in the perimenopause and menopause. Spironolactone helps cystic acne as well as comedones. Spironolactone is only available on prescription. Spironolactone tablets are available in 3 sizes 25mg, 50mg and 100mg. You should only take Spironolactone for acne if this has been recommended to you by a Dermatologist.
We are very experienced in providing treatment with Spironolactone for acne in Birmingham. Spironolactone can be an excellent treatment for chronic acne.
How Aldactone Works
Aldactone is in a group of drugs called anti-androgens. Androgens are often thought of as male hormones, but both males and females have them.
Androgens like testosterone are present in the female body, but in lower levels. Still, some females produce more androgen hormones than needed.
Hormones, specifically androgens, have been linked to the development of acne. Aldactone works by blocking androgen receptors in the body. This stops cells from responding to androgen hormones.
Simply, Aldactone limits the hormonal fluctuations that can cause breakouts. It is therefore only effective against hormonal acne.
Some females get acne because of fluctuating hormones. These patients may have good results with Aldactone.
Also Check: What Lotion Is Good For Acne
Who Will Be Blinded
Our study is a randomized double-blind trial during the first 6 months , and an open tria during the last 6 months of follow up. The female patients will be randomized either to the acne routine care arm, i.e. cycline or to the experimental drug arm .
The patients and the investigators and their teams will only be blinded to the treatment assigned during the first 6 months. As Karanicolas et al. pointed out in their article from 2010, their study should have been masked to the biostatisticians until analyses had been performed, to reduce the study bias .
Blinding will be removed for all patients after 6months of evaluation – once the primary endpoint has been measured – whatever the result, to limit the constraints for the patients in the doxycycline arm. If blinding were maintained, patients in the doxycycline arm would have to take a placebo for up to 6 months in addition to the 3 months already taken. The objective of the last 6 months of follow up is to assess the maintenance of the efficacy of each treatment during this time.
Taking Aldactone With Food
You can take Aldactone with or without food. But you should take the drug consistently for every dose.
This means that if you start taking Aldactone with food, you should take the drug with food for the rest of your doses. And if you take Aldactone without food, you should keep taking it without food for your other doses.
You May Like: How To Clear Butt Acne
Are There Dietary Concerns When Taking Spironolactone
The most important thing is to follow your prescribing medical providers instructions about diet, which may include a recommendation to lower your salt intake. In general, people taking spironolactone should avoid excess potassium, which can be found in foods like:
Your Curology provider can work with you to figure out which of these medications are the best ones for you.
What Is The Most Effective Dosage Of Spironolactone To Fight Acne
Is there a certain dosage that is considered the most effective for combating hormonal acne? A person is petite mid-thirties female. started on 100mg but felt poorly the first month they was on the prescription. They reduced their intake to 50mg, but wonder if they will not see the results with this lower dose?
Also Check: How To Get Rid Of Acne After Steroids
How To Get Spironolactone
Spironolactone can only be obtained through a prescription from a licensed medical provider. Right now, Curology does not prescribe spironolactone.
An in-person medical provider may be your best bet for obtaining spironolactone. Theyll consider your overall health, and they may want to monitor your electrolytes when adjusting to spironolactone. Thats partially because spironolactone is a diuretic, which influences your fluid retention and causes you to urinate more frequently.
What Clinical Evaluation And Laboratory Testing Should Be Done Before Initiation Of Therapy With Oral Spironolactone And What Follow
A thorough general examination, including past medical history, medication list, past surgical history, family history, social history, and physical examination are important components of the overall management of the patient. Also a gynecological and an obstetric history are both important in female patients and may be particularly relevant before prescribing a hormonal therapy, such as spironolactone or an OC. It is important to include in the dermatological physical examination of the adult woman with facial AV an assessment of chest, back, shoulders, and upper arms, as AV often involves these locations in addition to the face. It is recommended that each clinician incorporate his or her own consistent system to grade acne severity in different body locations so accurate comparisons can be made from visit to visit. If present, the type, location, and severity of acne scarring should also be documented. Other factors, such as alopecia, hirsutism, and skin oiliness , may also be assessed and documented.
You May Like: How Much Is Laser Resurfacing For Acne Scars