Isotretinoin for acne vulgaris – an update on adverse effects and laboratory monitoring

This study was carried out to evaluate the efficacy, safety and adverse effects of topical isotretinoin 0.05% gel in the treatment of acne vulgaris. This prospective study was undertaken in Skin & VD outpatient department of Rajshahi Medical College Hospital, Rajshahi. One hundred patients with mild tomoderate acne vulgaris were enrolled and were instructed to apply isotretinoin 0.05% gel once daily at night for 12 weeks. Patients were followed up at 2,4,8 and 12 weeks for efficacy and tolerability. Efficacy was measured by counting facial inflammatory and noninflammatory lesions and by grading acne severity. Cutaneous tolerance was assessed by determining erythema, scaling and burning with pruritus.Response was excellent in 80%of cases.None of the cutaneous reactions was severe, all were mild and well tolerated.Nobody had to discontinue the therapy for side effects. This study confirms that isotretinoin 0.05% gel is safe and effective topical therapy for mild to moderate acnevulgaris.TAJ 2016; 29(2): 1-5

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A rational pharmacotherapeutic study of comparative safety among topical anti-acne 1% nadifloxacin monotherapy, 0.1% adapalene monotherapy, 0.025% tretinoin monotherapy, 1% nadifloxacin and 0.1% adapalene combination therapy and 1% nadifloxacin and 0.025% tretinoin combination therapy, in mild to moderate acne vulgaris, in tertiary care hospitals

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20193662 ◽

2019 ◽

Vol 8 (9) ◽

pp. 1959

Author(s):

Moumita Hazra

Keyword(s):

Adverse Effects ◽

Combination Therapy ◽

Acne Vulgaris ◽

Tertiary Care ◽

Skin Irritation ◽

Combination Therapies ◽

Global Alliance ◽

Topoisomerase Iv ◽

Significant Difference ◽

Anti Inflammatory

Background: Topical adapalene and tretinoin, are comedolytic, anti-comedogenic and anti-inflammatory, on RAR (α, β, γ) receptors binding. Adapalene enables quicker follicular penetration, by lesser anti-AP-1 (c-Jun, c-Fos) and no CRBPII mRNA actions, causing chemical stability, lipophilicity and less photo-lability, producing lesser photosensitivity and no skin irritation, unlike tretinoin; wherein reducible by overnight application and combination therapy, slow-release polymers or emollients, respectively. Topical nadifloxacin is bactericidal, anti-inflammatory and comedolytic, with inhibitory effect on DNA gyrase, DNA topoisomerase IV and IL-1α, IL-6, IL-8. The Global Alliance to Improve Outcomes in Acne Guidelines recommend synergistic and additive combination therapies, which enhance therapeutic efficacy and reduce adverse effects. Due to inadequacy of data, this study was conducted, to compare the safety among topical anti-acne monotherapies and combination therapies, and to easily detect any adverse effect producing component in the topical combination therapy.Methods: In this multi-centre, prospective, randomised, open-labelled, comparative study, groups A, B, C, D and E (20 patients each), applied topical 1% nadifloxacin monotherapy, 0.1% adapalene monotherapy, 0.025% tretinoin monotherapy, 1% nadifloxacin and 0.1% adapalene combination therapy and 1% nadifloxacin and 0.025% tretinoin combination therapy, respectively, over their facial mild to moderate acne lesions, once daily overnight; and adverse effects, like erythema, scaling, dryness, prutitus, burning, or stinging, were assessed on 0, 15, 30, 60, 90 days and follow-ups, by Local Irritation Scale.Results: In all 5 groups, no adverse effects were observed, with no statistically significant difference among the observations.Conclusions: The therapies were well tolerated and safe among all 5 groups.

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Efficacy and Safety of 25% Trichloroacetic Acid Peel Versus 30% Salicylic Acid Peel in Mild-to-Moderate Acne Vulgaris: A Comparative Study

Dermatology Practical & Conceptual ◽

10.5826/dpc.1103a63 ◽

2021 ◽

pp. 2021063

Author(s):

Surabhi Dayal ◽

Satbir Singh ◽

Priyadarshini Sahu

Keyword(s):

Salicylic Acid ◽

Adverse Effects ◽

Comparative Study ◽

Clinical Efficacy ◽

Trichloroacetic Acid ◽

Acne Vulgaris ◽

Efficacy And Safety ◽

Inflammatory Lesions ◽

Treatment Groups ◽

Proven Efficacy

Background: Both salicylic acid (SA) and trichloroacetic acid (TCA) have proven efficacy with goodsafety profiles in the treatment of acne vulgaris. Objectives: This study compared the clinical efficacy and safety of 25% TCA and 30% SA peels in thetreatment of mild and moderate acne vulgaris. Methods: Patients with mild or moderate acne vulgaris were randomized into 2 groups of 25 personseach, and treated with either the TCA peel or the SA peel at 2-week intervals for 12 weeks. Evaluationof active acne was done by individual lesion counts (comedones, papules and pustules) and calculationof the Michaelsson acne score (MAS). Results: Both peels led to significant decrease in individual lesion counts and MAS compared to baselinevalues, without significant differences between the treatment groups. Thus, the peels had equivalentefficacy against acne vulgaris. The TCA peel was better in treating non-inflammatory lesions,while the SA peel was better for inflammatory lesions, but the differences were not significant. Noserious adverse effects were recorded, but more patients in the TCA peel group experienced burningand stinging sensations. Conclusion: The efficacy of 25% TCA is comparable to that of 30% SA in mild-to-moderate acnevulgaris, but safety and tolerability were better with the SA peel than TCA peel.

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High-Dose Isotretinoin Treatment and the Rate of Retrial, Relapse, and Adverse Effects in Patients With Acne Vulgaris

JAMA Dermatology ◽

10.1001/jamadermatol.2013.6746 ◽

2013 ◽

Vol 149 (12) ◽

pp. 1392 ◽

Cited By ~ 55

Author(s):

Rachel C. Blasiak ◽

Christopher R. Stamey ◽

Craig N. Burkhart ◽

Aida Lugo-Somolinos ◽

Dean S. Morrell

Keyword(s):

Adverse Effects ◽

Acne Vulgaris ◽

High Dose

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Topical Clindamycin in the Treatment of Acne Vulgaris

KYAMC Journal ◽

10.3329/kyamcj.v1i2.13316 ◽

2013 ◽

Vol 1 (2) ◽

pp. 59-64

Author(s):

Shahnaj Sultana ◽

Md. Nure Alom Siddiqul ◽

Md. Moksedur Rahman ◽

Muhammad Afsar Siddiqul ◽

Abdullah Al Amin

Keyword(s):

Side Effects ◽

Adverse Effects ◽

Prospective Study ◽

Acne Vulgaris ◽

Topical Therapy ◽

Clindamycin Phosphate ◽

College Hospital ◽

Patient Response ◽

Medical College ◽

Continued Use

This study was conducted to evaluate the efficacy, safety and adverse effects of topical clindamycin phosphate 1% lotion in treating acne vulgaris in a group of Bangladeshi people. This prospective study was undertaken in skin & VD out patient department of Rajshahi Medical college Hospital, Rajshahi. A total of 30 patients, 15 (50%) males and 15 (50%) females between ages 15 and 35 years (mean 18 years) with acne of grades I, II and III of duration <3 years to 10 years (mean 3.33 years) were studied. Clindamycin phosphate 1% lotion was administered twice daily for 12 weeks to each patient. Response was excellent in 73.33%, good in 20%, fair in 3.33% and poor in 3.33% of cases. Clinical adverse effects were noted in 20% of cases where oiliness was in 6.67%, irritation and burning in 3.33%, puritans in 3.33%, erythema i3.33% and peeling in 3.33% of cases. None of the reactions was severe, all were mild and well tolerated and most occurred within the first month of initiation of treatment and resolved with continued use of drug and completely cured after the treatment completed. No body had to discontinue the therapy for side effects. 80% of the total patients had no side effects. This study confirms that clindamycin is safe and effective topical therapy for mild to moderate acne vulgaris.DOI: http://dx.doi.org/10.3329/kyamcj.v1i2.13316KYAMC Journal Vol.1(2) January 2011, 59-64

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A Pharmacovigilance Study of Topical Acne Monotherapy with 0.1% Adapalene, and A Molecular Analytical Review of Adapalene in Evidence-Based Dermatopharmacological Treatment

International Journal of Pharmaceutical Sciences Review and Research ◽

10.47583/ijpsrr.2021.v70i02.032 ◽

2021 ◽

Vol 70 (2) ◽

Author(s):

Dr. Moumita Hazra

Keyword(s):

Adverse Effects ◽

Acne Vulgaris ◽

Global Evaluation ◽

Evidence Based ◽

Molecular Pharmacology ◽

Once Daily ◽

Significant Evidence ◽

The Face ◽

Analytical Review ◽

User Friendly

Acne vulgaris causes cosmetic impairment. User-friendly anti-acne monotherapy with adapalene has activity against the acne pathophysiology, with very minimal adverse effects. Retinoids, like adapalene, are comedolytic and anti-inflammatory. This study was conducted as a pharmacovigilance study of topical acne monotherapy with 0.1% adapalene, and a molecular analytical review of adapalene in evidence-based dermatopharmacological treatment. A prospective, open- labelled study was done, on 75 patients, with mild to moderate acne. Patients applied 0.1% adapalene topical monotherapy, once daily in the evening, over affected areas on the face, and left overnight. Efficacy was measured by percentage reduction in non-inflammatory, inflammatory and total lesion counts on 0, 15, 30, 60 and 90 days; and severity of lesions was assessed by Investigator’s Global Evaluation Scale and the occurrence of adverse effects like erythyma, dryness, scaling, burning and pruritus, were assessed by the Local Irritation Scale, among the patients receiving the monotherapy. An analytical review of the molecular pharmacology of adapalene in evidence-based dermatopharmacological treatment was thoroughly performed. The patients showed highly significant reduction in total lesion counts from baseline. No serious adverse effects were observed; and the observations were statistically non-significant. The molecular analytical review described significantly effective evidence-based dermatopharmacological response mechanisms of adapalene therapeutics. Topical 0.1% adapalene monotherapy was effective and safe, with significant evidence-based molecular dermatopharmacological efficacy.

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Is Oral Omega-3 Effective in Reducing Mucocutaneous Side Effects of Isotretinoin in Patients with Acne Vulgaris?

Dermatology Research and Practice ◽

10.1155/2018/6974045 ◽

2018 ◽

Vol 2018 ◽

pp. 1-4 ◽

Cited By ~ 2

Author(s):

Mina Mirnezami ◽

Hoda Rahimi

Keyword(s):

Side Effects ◽

Adverse Effects ◽

Acne Vulgaris ◽

Control Group ◽

Case Group ◽

Omega 3 ◽

Double Blind ◽

Severe Acne ◽

Double Blind Clinical Trial ◽

And Control

Background. Acne vulgaris is an inflammatory disease of pilosebaceous units which may cause permanent dyspigmentation and/or scars if not treated. Isotretinoin is recommended in the treatment of recalcitrant or severe acne, but it is associated with common adverse effects that frequently result in patients incompliance and discontinuation of the drug. The present study was designed to assess the efficacy of oral omega-3 in decreasing the adverse effects of isotretinoin. Materials and Methods. In this randomized double-blind clinical trial, a total of 118 patients with moderate or severe acne were randomly divided into two (case and control) groups. The control group was treated with isotretinoin 0.5 mg/kg, and the case group was treated with the same dose of isotretinoin combined with oral omega-3 (1 g/day). The treatment was lasted for 16 weeks and mucocutaneous side effects of isotretinoin were recorded and compared between the two groups in weeks 4, 8, 12, and 16. Results. Cheilitis (at weeks 4, 8, and 12), xerosis, dryness of nose at all weeks, and dryness of eyes (at week 4) were less frequent in the group that received isotretinoin combined with oral omega-3 compared to the group that received isotretinoin alone. Conclusion. Administration of oral omega-3 in acne patients who are receiving isotretinoin decreases the mucocutaneous side effects of isotretinoin. This trial is registered with IRCT201306238241N2.

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