Procura 20mg/10mg is an acne treatment (for severe acne cases like acne conglobata, nodular acne, and scarring acne cases) which specialists are the only ones allowed to prescribe . Isotretinoin is not a regular acne treatment, as before taking the drug, patients should undergo blood testing and other compatibility tests due to its side effects.
There are many considerations for females taking Isotretinoin due to the drug’s teratogenicity . Patients are required to take pregnancy tests before being administered with any Isotretinoin product like Procuta in order to prevent incidences of malformations in fetuses. Male patients, however, are not in much danger in terms of fertility, so there are not many considerations for male patients planning to take the medication .
This medication, Procuta, is manufactured by Expanscience Laboratoires dba Mustela which is located in France, and the company makes two dosage forms for the product—the 20 mg and the 10 mg type. Although Expanscience/Mustela is a manufacturer of various types of finished doses, the manufacturer does not have other available variations for Procuta. The drug is available only in oral soft pill form.
About Expanscience Laboratoires dba Mustela
The company Expanscience Laboratoires dba Mustela is a French manufacturer of dermo-cosmetics and pharmaceutical products . The company’s thrust is towards the development and manufacture of products related to osteoarthritis and skin care . The company has been in the pharmaceutical business for more than 60 years .
The products manufactured by the company involve products for rheumatology/osteoarthritis, dermatology, dermo-cosmetics, and dental care . Its product line, Mustela, is famous for its products for young moms, babies and children . Now, Mustela is aiming to create pediatric and obstetric dermatology products which are natural and free from parabens, phthalates, and other chemicals for safe and effective use by the patients .
The company is known for sourcing its active ingredients from plant sources, which is compliant with the Standard ISO 26000 and UEBT (Union for Ethical BioTrade) .
Scientific Studies on Isotretinoin
There are a number of studies attesting to the effectiveness of Isotretinoin in the treatment of acne in patients. The need for the use of Isotretinoin in patients especially for individuals with severe acne increased as the need for the treatment of acne is present since the disease does not only cover the physical aspect of patients; acne affects the psychosocial aspect of patients too. But though effective, Isotretinoin use has been associated with a great number of adverse reactions seen in patients undergoing Isotretinoin therapy. The study of Prevost and English in 2013, “Isotretinoin: update on controversial issues” reviewed the adverse effects related to the use of Isotretinoin in patients . According to the study, some of the patients taking the medication were observed to have inflammatory bowel disease, depression, and suicide ideation . Since its approval as an acne treatment in 1982, the drug has been widely used in the treatment of acne despite the side effects. Since the drug belongs to the teratogenic drugs category, patients (the female ones) are asked to join the iPledge program in order to prevent pregnancies and prevent the occurrence of fetal abnormalities in pregnant women treated with Isotretinoin .
Since Isotretinoin is categorized as a highly teratogenic drug, studies were also conducted to determine the number of pregnancy terminations related to the intake of Isotretinoin in patients. Authors from New Zealand, Moodie et al studied the rate of pregnancy terminations related with Isotretinoin use (“Terminations of pregnancy associated with isotretinoin use in New Zealand”) . The study was given funded access to involve data from the registered dermatologists, GPs, and nurse practitioners related to the number of pregnancy terminations related to the use of Isotretinoin in female patients in New Zealand . It was determined that the pregnancy termination rate for the use of Isotretinoin in females is 73 per 10,000 based on the 39 pregnancy terminations determined during the end of June 2008 . According to the authors, the figures are not absolute as the research could have been expanded more if not for limited funding . There is a recommendation for practitioners to enforce more knowledge regarding the risks of Isotretinoin use in females in order to decrease the incidence of pregnancy terminations and fetal malformations due to Isotretinoin use in females .
Because Isotretinoin is known to have a teratogenic effect, researchers also suspected that the drug might also have an effect on some of the aspects of the female reproductive system. Sikar Aktürk et al (2014) in their study, “The effects of isotretinoin on the ovarian reserve of females with acne” aimed to determine the effects of Isotretinoin on the female ovarian reserves, as there have been no studies done on Isotretinoin’s effect regarding the subject . In order to determine Isotretinoin’s action on the female ovarian reserve, 22 patients were tested for their AMH (anti-Müllerian hormone) levels before and after treatment with Isotretinoin due to acne. Another group of 22 patients were also tested for AMH and served as the control group . The results showed that there was a statistically significant decrease in the serum AMH levels post Isotretinoin treatment, and the authors mentioned that the decrease in the AMH levels is not beneficial (and is detrimental) to the ovaries .
Description and Mechanism of Action of Isotretinoin
Isotretinoin or 13-cis-retinoic acid is the most effective treatment for acne in patients due to its ability to manage the sebum levels in the skin. This ability of Isotretinoin to manage the sebum levels can be attributed to its capacity to induce cell apoptosis (cell death) of the sebaceous cells, which eventually leads to the shrinkage of the sebaceous glands in the skin. This lessening of the sebaceous gland size then leads to the lessening of the oil/sebum production in the skin. This action benefits the acne patients because sebum is the one causing the proliferation of acne lesions, hyperkeratinization, and the blockage of pores/glands/follicles found in the skin.
Another major factor in the proliferation of severe acne is the colonization of the bacteria P.acnes in the skin. The bacteria colonize skins which are rich in sebum, as the bacteria’s metabolism depends on sebum. The waste material excreted by the bacteria triggers the skin’s inflammatory response which exacerbates the existing acne conditions in the skin and the increase the number of acne lesions present. Since Isotretinoin is able to manage the sebum levels, the drug also indirectly targets the bacterial presence and the inflammatory response, which eventually results in significant improvement of patients treated with Isotretinoin.
Procuta Effects for Acne/Wrinkles
There are expected clinical benefits of Isotretinoin use for acne patients and the most significant of those benefits is its ability to clear out acne in patients. Patients can expect almost a complete clearing of their acne lesions after a round of Isotretinoin treatment, although there are cases when the patients require more than one round to be able to see significant before and after results.
Aside from its action on the elimination of visible acne lesions via its inhibition of sebum production, there are also studies for Isotretinoin’s action on acne scars; Isotretinoin is also linked to the improvement of acne scars in patients with scarring acne conditions. Although it is not yet 100% proven, a significant number of dermatologists are known to use Isotretinoin for the treatment of scars, wrinkles, and stretch marks, due to some study results linking Isotretinoin to skin fiber regeneration in patients.
Recommended Doses and Duration of Therapy
A number of physicians are recommending an initial dose of 0.5 mg/kg per day of Isotretinoin in patients and for an initial period of a few weeks, although the dose is variable and may be changed according to patient response . In some patients with underlying medical conditions, the dosage of Isotretinoin products like Procuta may be lower, at only about 10-20mg per day.
Treatments using Isotretinoin usually take less than 6 months, although the treatment duration also varies with patient response. Physicians indicate the use of Isotretinoin until the clearing of acne is evident in patients. In some cases where relapses are observed, the patients are prescribed multiple rounds of treatment until permanence of acne clearing is attained. Regarding dosage administration, there is no fixed amount of the dosage for patients are personalized according to the tolerance and response of the patients.
Side effects and Warnings
There are side effects related to the use of Isotretinoin in patients, but according to the manufacturer’s information, not all patients get to experience the side effects , although the patients are most likely to experience them with Isotretinoin use. There are psychological, metabolic, nervous, digestive, liver, muscular, and kidney side effects reported to be related to Isotretinoin use, although these side effects are rare.
The non-serious (but common) side effects of Isotretinoin use includes skin drying (facial and labial), chapping of lips, rashes, nasal dryness, nasal bleeding, runny nose, ocular dryness, musculoskeletal pain (back, muscle, and joint pain), and anemia and related cases .
Also, there are instances that patients experience worsening of their acne cases a few weeks into acne treatment, although the condition should improve with the use of Isotretinoin products like Procuta .
Patients are advised not to take Procuta if they are allergic to soybean or nut oil as the product contains soybean oil . Since Isotretinoin also contains vitamin A, medications containing Vitamin A are not advised to be taken with the product since the side effects can be exacerbated by these drugs too .
Aside from Vitamin A and similar products, antibiotics are also contraindicated with Isotretinoin use, along with hormones like progesterone, steroids, and other medications. Herbal supplements, vitamin/mineral supplements, and OTC medication should also be taken with care, as they may interfere with Isotretinoin’s effects or side effects in the patients’ bodies.
Although Expanscience, the maker of Mustela products is a well-known company, there are no product reviews available for Procuta 20mg/10mg. Product reviews would have been a great help in giving other patients an idea of how the product works, but since there are none available, assumptions regarding the product effectiveness can only be made.
But though the product did not have personal accounts from the patients who were able to use it, the product may still be effective as it contains Isotretinoin which is very potent in the management of acne in patients. The product is also manufactured by a well-established company which is specialized in the manufacture of effective and safe dermo-cosmetic products used by consumers worldwide. It would have been better if Procuta had reviews, so that other patients will have an idea on the firsthand experience of others who have already tried using the product.
Price, Available Forms and Dosage
Procuta is available in 10 mg and 20 mg forms, but although the product has its own page on the company profile, there is no vendor information available for it on the web. Procuta may be exclusively distributed in stores worldwide and is not accredited for online sale.
The product is available for sale in the USA, the UK, Europe, and France, but the product cannot be bought online for the lack of suppliers vending the product. So although the product may be found in local drugstores, the patients from the USA, Canada, and Australia are not able to have the products shipped to their doorsteps. They can inquire at the local pharmacy, though, as the product may be sold there. Legalities may be one of the factors involved in the distribution of the product, especially online.
Conclusion and Rating
Procuta 20mg/10mg soft capsules are without reviews, but the effectiveness of the product is not measured by patient reviews alone. The product is manufactured and distributed by Expanscience Laboratoires dba Mustela, which is a world-famous manufacturer of dermo-cosmetics and pharmaceutical products. Its Mustela product line is famous for being safe and effective for babies, children, and mothers, and continues to be recognized up to this day.
Although no reviews were found for Procuta, I still think that the product deserves to be rated 3 out of 5 and recommended for the patients who have been prescribed with Isotretinoin for their can condition. Isotretinoin, as an active ingredient, is very effective in the treatment of acne in patients, so there is no question regarding the effectiveness of acne products containing Isotretinoin like Procuta. As for the manufacturer, Expanscience is one of the world’s major players in the dermo-cosmetics field, so patients can be assured that Procuta is manufactured under stringent guidelines in order to maintain the company’s high-quality manufacturer status.
Procura Wiki Facts
- Brand: Procura
- Active Ingredient: Isotretinoin
- Treatment: Acne
- Manufacturer: Expanscience Laboratoires dba Mustela
- Country of Manufacture: France
- Availability: USA, EU, UK, France
- Doctissimo.fr: Drug Guide. Available from: http://www.doctissimo.fr/medicament-PROCUTA-GE.htm
- Expanscience.com: PROCUTA® GE 20 MG. Available from: http://www.expanscience.com/fr/produits/dermatologie/procuta-ge-20-mg
- Expanscience.com: COMPANY. Available from: http://www.expanscience.com/en/expanscience/company
- Expanscience.com: PRODUCTS. Available from: http://www.expanscience.com/en/products
- Expanscience.com: MUSTELA RANGE. Available from: http://www.expanscience.com/en/products/dermo-cosmetics
- Expanscience.com: PLANT SUPPLY CHAINS. Available from: http://www.expanscience.com/en/cosmetic-active-ingredients/expertise#plant-supply-chains
- Prevost N, English JC. Isotretinoin: update on controversial issues. Journal of pediatric and adolescent gynecology. 2013 Oct 31;26(5):290-3. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~nfGbYM:8:@[email protected]@/cgi-bin/sis/search2/d?./temp/~fmeTdn:[email protected]
- Moodie P, Jaine R, Arnold J, Metcalfe S, Bignall M, Arroll B. Terminations of pregnancy associated with isotretinoin use in New Zealand. The New Zealand Medical Journal (Online). 2011 Jul 29;124(1339). Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~nfGbYM:14:@[email protected]@/cgi-bin/sis/search2/d?./temp/~fmeTdn:[email protected]
- Şikar Aktürk A, Abalı R, Yüksel MA, Güzel EÇ, Güzel S, Kıran R. The effects of isotretinoin on the ovarian reserve of females with acne. Gynecological Endocrinology. 2014 Jan 1;30(1):30-3. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~nfGbYM:13:@[email protected]@/cgi-bin/sis/search2/d?./temp/~fmeTdn:[email protected]