Dercutane 20mg/10mg Aldo Union is a generic brand of Isotretinoin. It is manufactured by the Spanish company IFC laboratories. It is available in 5mg, 10mg, 20mg, 30mg, and 40mg doses . Isotretinoin was first launched as Accutane by Hoffmann-La Roche, which is the innovator company. After the expiry of the patent, several generics have become available worldwide.
Dercutane is used for the treatment of nodular acne, which is a severe form of acne vulgaris (commonly known as just acne). Acne is the most common dermatological disease, affecting mainly teenagers and young adults. It is a cosmetic concern, as untreated or poorly managed it can lead to skin scarring and pigmentation, which may further result in psychological problems for the patient.
There are lots of generic manufacturers of isotretinoin, but Dercutane provides the wide range of dose forms, making it easier to choose the right dose for the patients and their prescribers. Isotretinoin is usually recommended for the period of 4-6 months, though side effects are common with it, they are tolerable. It is a highly teratogenic product, which means it is contraindicated in pregnancy as a child conceived or born while on therapy with isotretinoin has high chances of being born with birth defects.
About IFC laboratories
Dercutane is the product manufactured by IFC Laboratories, which is a part of IFC group, Spain. The company started its journey in Spain and later expanded to several countries. Apart from Spain, company has manufacturing units in Germany, Portugal, Italy and Brazil. The product range of the company is distributed in more than 50 countries.
IFC group specializes in producing dermatology range of products. It provides both cosmetics and medicines for skin care and treatment. As per company’s website, they invest 10% in R&D so that they could continue to produce innovative products.
The company was first to discover and patent antioxidant and sun photo immunoprotection based on the Polypodium leucotomies fern extract. Today, it has a team of more than 400 people employed globally. The company is also committed to various social projects. It is collaborating with “What really matters foundation” to fulfill its social obligations .
Scientific Studies on Isotretinoin
Since its introduction in 1982 for the treatment of severe acne, isotretinoin has revolutionized the treatment of acne. During last three decades, lots of long-term research has been done regarding the efficacy and safety of isotretinoin. In the clinical study by Lehucher-Ceyrac D, Weber-Buisset MJ “Isotretinoin and Acne in Practice: a Prospective Analysis of 188 Cases Over 9 Years”, 188 patients with an average age of 25 years were treated for severe acne. Patients were given isotretinoin in the dose ranging from 0.5 to 1mg/kg/day. The patients were classified into three categories after therapy, depending on the clinical results. 111 patients achieved immediate and long-term remission of a single course of treatment, while the second group of 54 achieved remission only after 2 or 3 courses of treatment and the third group of 23 patients only got partial remission from therapy with isotretinoin. In first two groups, there wasn’t much difference in age and health status, while the third group consisted of patients having other endocrinological problems. Hence from this clinical study, it was concluded that isotretinoin is quite effective in almost 90% of patients with severe acne, while in minority of cases (around 10%) other hormonal causes should be taken into consideration .
In another study by Cyrulnik AA et al. “High‐dose Isotretinoin in Acne Vulgaris: Improved Treatment Outcomes and Quality of Life” 80 patient with nodulocystic acne were given isotretinoin in a dose greater than 1.3mg/kg/day, patients were followed up for 3 years for relapse. The study aimed to establish the efficacy and safety of high-dose isotretinoin in patients. After the high dose therapy of isotretinoin for almost 6 months, all patients (100%) were disease free, and there was relapse rate of 12.5%. The author of the study concluded that high-dose therapy with isotretinoin is highly efficient and still safe enough. But since the sample size of the trial was small, so author found that there was a need for larger, a multi-centered study based on this treatment strategy .
There is another entirely different approach to the treatment of acne, this method is of low dose isotretinoin, given for a longer period of time. Advocates of this approach claim that this results in almost same results as high dose therapy, but better tolerance. Rademaker M et al. did a research titled “What Does 30 Years of Usage Tell Us?” where the authors found that if the patients were given a low dose of isotretinoin ( as little as 5mg/day) for the period of 6 months or longer, 70-80% patients achieved long-term remission of a single course. This approach results in lower side effects, though author noted that teratogenicity remained a major concern .
It is also common for the patients to ask that should they take treatment with food, or after food. In a study “Food Increases the Bioavailability of Isotretinoin” by Colburn WA et al., the author tried to explore the effect of food on the pharmacokinetics of isotretinoin. The study was able to establish that isotretinoin had 1.5 to 2 times greater bioavailability when taken an hour before or after the meal, as compared to therapy during fasting. It was also noted that if isotretinoin was taken with food, then Cmax was lower in comparison to taking isotretinoin 1 hour before or after the meal. Hence it could be concluded that food increases the bioavailability of isotretinoin and also improves the tolerance .
Description and Mechanism of Action of Isotretinoin
Isotretinoin is analogous to vitamin A in its structure. Though the exact mechanism of action of isotretinoin is unclear, during three decades of clinical observation, it is now known that Isotretinoin decreases sebum excretion, influences cell growth, and apoptosis, it inhibits the growth of tumor cells and has an immunomodulatory effect. It suppresses acne at all stages and is most effective treatment till date.
Dercutane Effects for Acne and Wrinkles
Acne treatment with Isotretinoin is recommended when desired results are not achieved by topical creams and oral anti-infective therapy. Isotretinoin has shown excellent results in severe or resistant cases of acne. With the proper therapeutical approach, more than 80% patients can expect clearing of skin and long-term remission of acne with a single course, though a minority of patients may need to repeat the therapy. Isotretinoin not only relieves from acne, but also from scars and pigmentation. There have been off-label uses of isotretinoin for wrinkles and stretch marks. Users benefit from its anti-ageing effect.
Recommended Doses and Duration of Therapy
For most cases of acne recommended dose of Dercutane (isotretinoin) is 0.5mg to 1mg/kg/day, and it is taken for at least 4 months, depending on the severity of disease, longer treatment may be needed. Clinical experience with isotretinoin has also shown that it can be effective and better tolerated if taken at a lower dose of 5 or 10mg/day for 6 months or longer.
Side Effects and Warnings
Major concern while taking isotretinoin is its teratogenicity. Pregnancy should be avoided when taking isotretinoin as chances of birth defects are higher than 30%, it is recommended that during therapy double contraception is used. Pregnancy should be planned only after 1 month of discontinuation of treatment.
During therapy with Isotretinoin, dryness of lips and nose is very common, patient may also feel increased tiredness, over-exposure to strong sunlight, the wind, and cold must be avoided as skin becomes more sensitive to environmental irritants. In rare cases, it may cause an allergic reaction, hepatitis or pancreatitis. In extremely rare cases irritable bowel syndrome has also been reported.
Isotretinoin should be used with caution with corticosteroids and phenytoin as taking it together for a longer period of time may cause osteoporosis. Though isotretinoin is well tolerated with oral hormonal contraceptives in women, there are reports of increased failure rate with isotretinoin. Taking vitamin A should be avoided with isotretinoin as they may increase the adverse effects of each other due to similarities in their chemical structure. Isotretinoin can decrease the anticoagulant effect of warfarin. It should be avoided with tetracycline as there are reports of cranial hypertension.
From the customer reviews, one can say that generally customer are satisfied with Dercutane since the product is a prescription product, so customers are well aware of the side effects (chapped lips, dryness of eye and ear are quite common).
As one of the customer said “… acne disappears, increase your self-esteem so you can wash your hair with the frequency of an average person …posh clinics in Barcelona and Madrid give it in low doses as anti-aging treatment.”
Some of the customers feel frightened after reading the online reviews, there are lots of comments from customers where they discuss the effectiveness of a product or its side effects. Before making any conclusion, it should be understood that isotretinoin is quite efficient and safe, and a vast number of online reviewers are patients who are worried about the side effects, as some side effects, though tolerable, are quite common. Usually, patients who are satisfied with results and don’t experience any side effects don’t comment online or participate in discussions.
Price, Available Forms, and Dosage
This is a prescription product, and in many countries, the sale of the product is strictly controlled. Hence product isn’t easily available on the internet shops.
Conclusion and Rating
Isotretinoin is the most effective treatment of severe or resistant cases of acne vulgaris. It is taken for the long duration of 4 months or more, though mild side effects like dry lips, eyes, nose, and feeling of tiredness are common side effects. Generally, Dercutane 20mg/10mg is well tolerated.
There are two dosing strategies. First one is to start with high dose: this dosing strategy has been shown to be more effective and is usually for 4 months, but chances of adverse effects are greater. The second strategy is to take the product in lower doses like 5 or 10mg/day but for much longer period.
Isotretinoin is contraindicated in pregnancy as there are high chances of birth defect. It is recommended that before starting the therapy women should take a pregnancy test, and should use double contraception during treatment.
Though is not approved, Dercutane is also used as an anti-aging drug at small doses.
Considering the high effectiveness of Dercutane 20mg/10mg in the treatment of acne vulgaris, especially when all other options have failed, I would give the product a rating of 4 out of 5. I am not giving 5 out of 5 as there are many side effects of the product and in some cases, the patients may have to abandon therapy due to these side effects.
Dercutane Wiki Facts
- Brand: Dercutane
- Active Ingredient: Isotretinoin
- Treatment: Acne
- Manufacturer: IFC laboratories
- Country of Manufacture: Spain
- Availability: Spain, Germany, Italy, Portugal ++
- Dercutane. Product information. Available from: http://www.ifc-spain.com/medicamentos/dercutane.html.
- IFC Group. Company information. Available from: http://www.ifcgroup.net/eng/ifc-group-about-ifc.html#
- Lehucher-Ceyrac D, Weber-Buisset MJ. Isotretinoin and acne in practice: a prospective analysis of 188 cases over 9 years. Dermatology. 1993 Jul 1;186(2):123-8. Available from: http://www.karger.com/Article/Abstract/247322
- Cyrulnik AA, Viola KV, Gewirtzman AJ, Cohen SR. High‐dose isotretinoin in acne vulgaris: improved treatment outcomes and quality of life. International journal of dermatology. 2012 Sep 1;51(9):1123-30. Available from: http://onlinelibrary.wiley.com/doi/10.1111/j.1365-4632.2011.05409.x/full
- Rademaker M. Isotretinoin: dose, duration and relapse. What does 30 years of usage tell us?. Australasian Journal of Dermatology. 2013 Aug 1;54(3):157-62. Available from: http://onlinelibrary.wiley.com/doi/10.1111/j.1440-0960.2012.00947.x/full
- Colburn WA, Gibson DM, Wiens RE, Hanigan JJ. Food increases the bioavailability of isotretinoin. The Journal of Clinical Pharmacology. 1983 Nov 12;23(11):534-9. Available from: http://onlinelibrary.wiley.com/doi/10.1002/j.1552-4604.1983.tb01800.x/abstract
- Isotretinoin precautions. Available from: http://www.mayoclinic.org/drugs-supplements/isotretinoin-oral-route/precautions/drg-20068178
- Isotretinoin interactions. Available from: http://www.pdr.net/drug-summary/Absorica-isotretinoin-2411