Low‐cumulative dose isotretinoin treatment in mild‐to‐moderate acne: efficacy in achieving stable remission

Background Aimed at the reduction of post‐treatment relapse of severe acne, the cumulative dose of oral isotretinoin should be ≥120 mg/kg. However, data on the appropriate oral isotretinoin treatment regimen in mild and moderate acne are lacking. Objective The purpose of this study was to determine the efficacy of an isotretinoin‐sparing protocol in inducing permanent remission of mild and moderate acne. Methods In this open, prospective, non‐comparative study, 150 patients affected with mild‐to‐moderate acne were treated with isotretinoin until complete recovery and for a further month of treatment, independent of the total cumulative dose reached. Patients then underwent a 1‐year maintenance therapy with adapalene 0.1% cream. Patients were followed up for a further year, without any treatment. Results A total of 139 patients completed the study. Overall, patients received a mean of 80.92 mg/kg cumulative dose of isotretinoin. In the 2‐year follow‐up, relapse only appeared in 13 patients (9.35%). Conclusion Comparing our findings with published data, this isotretinoin‐sparing regimen was shown to be effective in inducing stable remission and preventing acne relapses in patients with mild‐to‐moderate acne. Low‐cumulative dose regimens may potentially lead to a lower incidence of side‐effects and to lower costs than higher doses.     

异维A酸隔日疗法和每日疗法治疗痤疮疗效比较

目的:观察异维A酸(泰尔丝)隔日疗法和每日疗法治疗痤疮的疗效,以及在保证疗效的前提下唾液腺分泌减少的发生率.方法:将受试者分为两组,即异维A酸隔日疗法B组(试验组)和每日疗法组(对照组).试验组中体重≥50kg者,隔日口服异维A酸10 mg,每日3次;体重＜50 kg者,隔日口服异维A酸10 mg,每日2次.对照组中体重≥50 kg者,每日口服异维A酸3次,每次10mg;体重＜50 kg者,每日口服异维A酸2次,每次10mg,两组患者疗程均为6周.结果:经过6周的治疗,试验组患者有效率为77.17%,对照组患者有效率为85.00%.第2、4、6周末时试验组和对照组患者唾液腺分泌减少的发生率分别为26%、31.25%、32.18%和28.87%、34.12%、48.68%.结论:异维A酸隔日疗法治疗痤疮的疗效与每日疗法相当,唾液腺分泌减少的发生率更低.     

异维A酸治疗中度寻常痤疮临床疗效观察

目的:评价异维A酸治疗中度痤疮的疗效和安全性。方法:采用随机、阳性药物平行对照的临床试验。试验组患者每日服用异维A酸(泰尔丝);对照组患者每日服用维胺酯,两组患者均治疗6周。治疗2、4、6周,对两组痤疮患者的粉刺、丘疹、脓疱、结节囊肿、皮脂溢出等评分比较。结果:试验组皮损的总评分差值从(0.2166±0.1291)分增至(6.2469±1.1826)分,对照组则从(0.1290±0.3191)分增至(5.6297±1.4489)分,两组间痤疮评分差值比较,差异有显著性。治疗结束时,试验组痊愈率和有效率分别为58.18%和100.00%,对照组分别为22.41%和82.75%,二组间疗效比较差异有显著性。试验组有23例患者出现局部不良反应,对照组有31例患者出现局部不良反应。结论:异维A酸治疗中度寻常痤疮疗效好于维胺酯。     

Efficacy of fixed low-dose isotretinoin (20 mg, alternate days) with topical clindamycin gel in moderately severe acne vulgaris

Background  In view of the potentially serious side-effects of standard isotretinoin (0.5–1.0 mg/kg per day) therapy for acne, we studied the safety and efficacy of low-fixed dose isotretinoin plus topical 1%clindamycin gel in the treatment of moderate grade of acne.
Methods  In this prospective, non-comparative study, 320 adult patients, with moderately severe acne were enrolled and treated with fixed-dose isotretinoin at 20 mg every alternate day (approximately 0.15 mg/kg/day to 0.28 mg/kg/day) for 6 months along with topical clindamycin gel. All female patients were assessed for polycystic ovarian disease. Patients were followed up for 6 months.
Results  A total of 305 patients completed the study. Overall, patients received a mean of 38.4 mg/kg cumulative dose of isotretinoin, and very good results were observed in 208 (68.20%), while good response was seen in 59 (19.34%) of patients. Failure of the treatment occurred in 38 (12.46%), while relapses occurred in 50 (16.39%) of patients. Relapses were commoner in females, and 37 of 43 (86.04%) patients had polycystic ovarian disease. Though mild chelitis (91%) and xerosis (43%) were common, laboratory abnormalities in the form of elevated hepatic enzymes (5%) and elevated serum lipids (6%) were rare.
Conclusion  Six months of treatment with fixed-dose, alternate-day isotretinoin (20 mg) plus topical 1%clindamycin gel was found to be effective in the treatment of moderate acne in adult patients, with a low incidence of side-effects.

Conflicts of interest

None declared     

异维A酸联合水杨酸治疗中重度痤疮的疗效观察

目的:探讨口服异维A酸胶囊联合30％超分子水杨酸治疗中重度痤疮的临床疗效.方法:将80例中重度痤疮患者随机分为对照组(40例)和观察组(40例),对照组给予异维A酸胶囊10 mg口服,一天2次,连续8周;观察组给予异维A酸胶囊的同时联合30％超分子水杨酸治疗,每隔4周治疗一次,共3次.比较两组患者总积分、临床疗效、不良...     

Alopecia areata and isotretinoin; coincidence or causal relation

Isotretinoin is a safe and useful medication for acne management. Adverse effects are mostly related to cutaneous and mucous membranes. We present a case of a 24‐year‐old female patient who was on treatment with isotretinoin for acne vulgaris Grade 4. After 6 months of treatment, the patient presented with localized patch of hair loss. Beginning of alopecia areata in patients with acne vulgaris could be regarded as a side effect of retinoids due to anti‐acne therapy. The exact mechanism by which retinoids cause hair loss is not known.     

A review of the European Directive for prescribing systemic isotretinoin for acne vulgaris

Since the introduction of generic oral isotretinoin there have been discussions around harmonizing the summary of product characteristics of each formulation. As a result of these discussions, a European Directive concerned with the prescribing of oral isotretinoin has been introduced and the FDA (Food and Drugs Administration) has recently implemented new regulations. The aims of this article are to summarize the history of the processes involved, outline the new recommendations and discuss the impact of these changes in clinical practice.     

Downregulation of S100a7a antimicrobial peptide in acne vulgaris patients after isotretinoin therapy

The S100a7a protein is expressed in keratinocytes, its level is increased in acne condition. As isotretinoin therapy is known to alter some of S100 peptides, these could be important specific targets for acne therapy and may have an important role in clinical remission. A randomized controlled trial was held in a dermatology clinic in Baghdad, where 30 patients with moderate to severe acne vulgaris condition aged 16–31 years were enrolled. Five milliliters of venous blood samples were taken before and after 6 weeks of isotretinoin therapeutic trial. A placebo‐control group of 26 acne patients was also enrolled. The S100a7a peptide was measured in both groups using the ELISA technique before and after the trial. High levels of serum S100a7a were found in acne patients of both groups before therapeutic trial. Following the trial, a significant statistical difference (p = .0003) was noticed between mean S100a7a protein level of study and control groups. By comparing the mean S100a7a protein level before and after isotretinoin therapy in the study group, a highly significant statistical difference was also found (p = .001). The current study showed a downregulatory effect of isotretinoin therapy on the S100a7a peptide mean level.     

Perceptions about oral isotretinoin treatment

There are some studies on the knowledge, beliefs, and perceptions of patients about acne vulgaris, however, there is no sufficient data on patients' beliefs about oral isotretinoin treatment (OIT). The aim of this study was to assess the knowledge, beliefs, and perceptions of the patients with acne vulgaris about the therapy of OIT and its side effects. A total of 214 patients with acne vulgaris in our outpatient clinic were included. Patients who were planned to treat with OIT were asked whether they had information about the treatment and its side effects. It was noted whether the patients accepted treatment after being informed both verbally and written about the OIT details. The study consisted of 133 female and 81 male aged 12–57 years. Most of the patients (78%) stated that they had heard of OIT. The most common source of the information on isotretinoin therapy was friends (57.6%). The dryness was the best‐known side effect. While 86.4% of patients (n: 185) accepted OIT, the group (14.4%) stated that “I have knowledge about side effects.” And refused to use the treatment. Most of the patients agreed to the treatment after explanation of dermatologist. Patients may be educated and informed via reliable medical sources to prevent bias and improve compliance to the treatment.     

Plasma dermcidin levels in acne patients,and the effect of isotretinoin treatment on dermcidin levels

Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. Dermcidin (DCD) is an antimicrobial peptide released from eccrine sweat glands and sebaceous glands. Studies investigating the role of DCD expression in acne development are scarce. The aim of this study was to determine the relationship between DCD expression and acne vulgaris and the effect of oral isotretinoin treatment on DCD levels. Two groups (one patient group and one control group) were included in the study. The patient group consisted of 30 patients with acne vulgaris who were given oral isotretinoin treatment for 6 months until the cumulative dose was attained. Plasma DCD levels were investigated before and 6 months after treatment. The control group comprised 30 volunteer individuals without acne vulgaris or any inflammatory dermatosis. Of the patients, 24 (80%) had Grade 3, 3 (10%) had Grade 1, and 3 (10%) had Grade 4 acne vulgaris, as determined according to the Pillsbury scoring method. The DCD levels in the control group were significantly higher than those in pretreatment patients (39.53 ± 20.2 vs. 28.60 ± 20.12, p = .004). Additionally, pretreatment DCD levels were significantly increased after 6 months of isotretinoin treatment in the patient group (28.60 ± 20.12 vs. 35.07 ± 24.02, p = .012). The mean pretreatment global acne grading system score of 20.86 ± 4.43 was decreased to 5.17 ± 1.91 in patients after treatment (p < .001). This study indicated that DCD plays an important role in the pathogenesis of acne. It demonstrates anti‐inflammatory properties in acne vulgaris. Moreover, it was shown that isotretinoin treatment may improve acne vulgaris by increasing DCD levels.     

Topical adapalene gel 0.1% vs. isotretinoin gel 0.05% in the treatment of acne vulgaris: a randomized open-label clinical trial

BACKGROUND: Topical application of isotretinoin and adapalene has proved effective in treating acne vulgaris. Both drugs demonstrate therapeutic advantages and less irritancy over tretinoin, the most widely used treatment for acne. They both act as retinoid agonists, but differ in their affinity profile for nuclear and cytosolic retinoic acid receptors. OBJECTIVE: To compare the efficacy and tolerability of adapalene gel 0.1% and isotretinoin gel 0.05% in the treatment of acne vulgaris of the face, in a randomized open-label clinical trial. METHODS: Eighty patients were enrolled and were instructed to apply adapalene gel 0.1% or isotretinoin gel 0.05% once daily over a 12-week treatment period. Efficacy determination included noninflammatory and inflammatory lesion counts by the investigator and global evaluation of improvement. Cutaneous tolerance was assessed by determining erythema, scaling and burning with pruritus. RESULTS: Adapalene and isotretinoin gels were highly effective in treating facial acne. Adapalene gel produced greater reductions in noninflammatory and inflammatory lesion counts than did isotretinoin gel, but differences between treatments were not statistically significant. Adapalene gel was significantly better tolerated than isotretinoin gel during the whole treatment period. CONCLUSIONS: The two gels studied demonstrated comparable efficacy. When adapalene and isotretinoin were compared, significantly lower skin irritation was noted with adapalene, indicating that adapalene may begin a new era of treatment with low-irritant retinoids.     

Mood changes and clinical decision making in adolescent patients on isotretinoin therapy for acne vulgaris

Although numerous studies have demonstrated no causal relationship between isotretinoin and depression or suicide, subtle mood changes and idiosyncratic mood symptoms have been reported in patients on isotretinoin treatment for acne vulgaris, and few studies have described the full range of mood symptoms and clinical course after a mood change arises. We reviewed 247 patients, ages 10–25 years, with acne vulgaris on isotretinoin and found that 26/247 (10.5%) patients experienced mood changes, the most common being depressive symptoms, anxiety, aggression, and emotional lability. Regardless of treatment management, 22/25 (88%) patients experienced improvement of mood symptoms to baseline, and 22/25 (88%) were able to complete their isotretinoin course without symptom recurrence. Our findings highlight the importance of monitoring for a broad range of mood changes in patients on isotretinoin, especially those related to a pre-existing mood disorder and including those which do not meet formal criteria for a psychiatric disorder.     

Evaluation of subclinical atherosclerosis in Turkish patients with acne vulgaris receiving systemic isotretinoin

Studies conducted on isotretinoin have shown that it may indirectly lead to atherosclerosis. The objective of this study was to determine the effect of systemic isotretinoin on subclinical atherosclerosis. The present study included 63 patients with acne vulgaris who had used isotretinoin for 6 months. Glucose, insulin, and homeostatic model assessment of insulin resistance levels; body mass index; waist circumference; blood pressure; lipid profile; and lectin‐like oxidized low‐density lipoprotein receptor‐1 (LOX‐1), high‐sensitivity C‐reactive protein, and oxidized low‐density lipoprotein (Ox‐LDL) levels were compared in the patients at the initiation and discontinuation of the treatment. At the discontinuation of the treatment, LOX‐1 and Ox‐LDL levels showed a significant increase (P < .001 and P = .040, respectively). Differences in waist circumference were positively correlated with an increase in LOX‐1 levels (r = .274; P = .030). Isotretinoin causes an increase in the levels of subclinical atherosclerosis markers. Although the present study sample size was small, we believe that caution should be exercised considering the risk of atherosclerosis during isotretinoin use in men with high waist circumference and cardiovascular risk factors; further studies are warranted in this regard.     

The psychological and emotional impact of acne and the effect of treatment with isotretinoin

Although knowledge concerning the dermatological treatment of chronic acne has grown considerably in recent years, relatively few studies have assessed the impact of effective physical intervention upon the psychoemotional functioning of patients. Hypotheses regarding the psychological impact of acne were developed using concepts drawn from evolutionary psychology. A sample of 34 patients (19 men and 15 women) with chronic acne were assessed for psychological, emotional and dermatological symptomatology using a variety of self-report questionnaires over four time-points during 16 weeks treatment with isotretinoin. Thirty-four patients completed the first assessment, 21 the second, 20 the third and 15 the fourth and final assessment. At the first assessment, prior to isotretinoin treatment, 15 patients (44%) reported clinically significant levels of anxiety, while six patients (18%) reported clinically significant depression. Women with acne were significantly more embarrassed than their male counterparts about their skin disease. Treatment with isotretinoin produced significant improvements across a wide variety of psychological functions, although the emotional status of patients appeared to be more resistant to change. Acne appears to be a condition which has the potential to damage, perhaps even in the long term, the emotional functioning of some patients.     

口服异维A酸痤疮患者的血脂特点：附89例分析

 目的: 了解口服异维A酸治疗痤疮患者的血脂特点。方法：对2018年8月至2019年2月于中山大学附属第三医院皮肤科门诊确诊的有口服异维A酸适应症的资料完整的痤疮患者进行回顾性分析。结果：共纳入89例患者,均接受每日口服20~30 mg异维A酸的治疗。患者初诊时血脂均在正常范围内,服药后出现血脂异常35例（39.32%）,其中TC合并LDL-C异常者共6例（17.14%）,仅LDL-C异常者共29例（82.85%）,血脂明显异常升高者共5例（14.28%）;未发现TG或HDL异常者;34例（97.14%）在服药第8周出现血脂异常,仅1例（2.86%）在第16周出现血脂异常。服药第8周、第16周TC、TG、LDL-C相比第0周水平均升高,差异有统计学意义（均P＜0.01）,而HDL-C相比第0周水平均降低,差异有统计学意义（P＜0.01）。第16周时TG水平较第8周升高,差异有统计学意义（P＜0.01）,而TC、LDL-C、HDL-C水平较第8周降低,差异有统计学意义（均P＜0.05）。TC和LDL-C均呈先升高后降低的变化趋势。结论：痤疮患者服用异维A酸后TC、TG、LDL-C有升高趋势,HDL-C有降低趋势;出现血脂异常的患者绝大部分仅表现为LDL-C轻微异常,在服药第8周出现,以后趋于稳定甚至下降。     

Evaluation of hematological parameters in patients using systemic isotretinoin with diagnosis of acne vulgaris

Objectives

Oral isotretinoin is the most effective treatment option in patients with acne. However, it can cause various hematologic and biochemical abnormalities. This study aimed to evaluate hematologic abnormalities during oral isotretinoin treatment in patients with acne.

Material and Methods

In this cross-sectional study, the hematologic and inflammatory parameters of 138 patients with acne using 0.3-1 mg/kg/day oral isotretinoin for at least 6 months were retrospectively analyzed.

Results

In the study, the female-to-male ratio was 2.83, and the mean age of the patients was 23.1 ± 5.8 years. At the third and sixth months of isotretinoin treatment, there was a statistically significant decrease in the neutrophil count compared to the pre-treatment values (p = 0.003 and p = 0.032, respectively). The platelet count showed the most statistically significant increase (p < 0.001) at the first month of treatment. The most statistically significant decrease in the neutrophil-to-lymphocyte ratio (NLR) was observed at the third month of treatment (p < 0.001). No significant changes were observed in hemoglobin, hematocrit, white blood cell count, mean corpuscular volume, and mean platelet volume.

Conclusions

There was a decrease in neutrophils and NLR and an increase in platelets during isotretinoin treatment, and these changes were usually mild. However, it would be appropriate to monitor blood counts during treatment in patients with neutropenia or thrombocytosis.