Comparison of efficacy and safety between Tacrolimus and Hydrocortisone acetate in 2-5 years old children with atopic dermatitis

Introduction: Atopic dermatitis is a recurrent inflammatory skin disease with intense pruritus as its hallmark symptom. It often follows a chronic, relapsing course. Objectives: This comparative study was done with an aim to find out the efficacy of Tacrolimus and Hydrocortisone acetate in 2-5 year old children with Atopic dermatitis. Methods: This clinical trial was carried out on two equal groups of 60 patients. Group A was treated with topical tacrolimus ointment (0.03%) and group B with hydrocortisone acetate ointment (1%). Follow up was done at week 1, 2, 4, 8 and 12 of treatment for assessment of improvement and adverse event, which was measured by overall clinical improvement in the physician's global evaluation of clinical response. Data was collected in a predesigned data collection sheet, and analysis was performed by SPSS program (Version 12). Results: Excellent, marked and moderate improvement were observed in 19 (63.3%), 9 (30.0%), and 2(6.7%) patients of tacrolimus group and 1(3.3%), 2(6.7%) and 27(90.0%) patients of hydrocortisone group respectively. Tacrolimus group had significantly better improvement than hydrocortisone group (p<0.001). Skins burning at application site were observed significantly more in tacrolimus group 8(26.7%) than in hydrocortisone group 2 (6.7%). 53 JAFMC Bangladesh. Vol 10, No 1 (June) 2014 Conclusion: The study showed tacrolimus ointment is more effective than hydrocortisone acetate in the treatment of atopic dermatitis in paediatric patients. DOI: http://dx.doi.org/10.3329/jafmc.v10i1.22924 Journal of Armed Forces Medical College Bangladesh Vol.10(1) 2014

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Efficacy of Narrow-Band Ultra Violet B versus Narrow-Band Ultra Violet B with Topical Tacrolimus Ointment (0.1%) in the Treatment of Vitiligo

Journal of Armed Forces Medical College Bangladesh ◽

10.3329/jafmc.v13i1.41031 ◽

2017 ◽

Vol 13 (1) ◽

pp. 86-89

Author(s):

Jweena Bintey Jamal ◽

Muhammed Ashraful Alam Bhuiyan ◽

Md Abdul Latif Khan

Keyword(s):

Narrow Band ◽

Excellent Result ◽

Ultra Violet ◽

Armed Forces ◽

Military Hospital ◽

Tacrolimus Ointment ◽

Topical Tacrolimus ◽

Group A ◽

Group B ◽

Response Score

Introduction: Several treatment options e.g. topical corticosteroids, phototherapy like narrow-band ultra violet B (NB-UVB) and psoralen+ultra violet A (PUVA) etc are available for vitiligo. But none is so effective in single but combined one is more effective and superior. Objective: To compare the efficacy of NB-UVB vs NB-UVB with topical Tacrolimus ointment (0.1%) in the treatment of Vitiligo. Materials and Methods: This descriptive cross-sectional study was conducted in Combined Military Hospital, Dhaka from October 2015 to April 2016. Total 100 patients with vitiligo were divided into 2 groups of 50 patients. NB-UVB was given for 04 weeks to Group-A. In Group-B patients, topical Tacrolimus ointment (0.1%) twice daily was advised with simultaneous NB-UVB. The patients were followed-up at the baseline of the 4th, 8th and 16th week. Results: Majority (46%) of the patients were from 25-34 years of age with a mean age of 27.4±12.6 years. Among all risk factors, Family history of Vitiligo was the most common risk factor and common skin type (Fitzpatrick) was Type IV (40%). At the end of 4th week, maximum cases of Group-B showed good response (score 3) with a mean score of 1.74. Whereas, maximum cases of Group-A showed poor response (score 1) with a mean score of 0.86. End of the 16th week, maximum cases of Group-B improved successfully. In the end, 20% patients of Group-A showed an excellent result; but it was 42% from Group-B. Conclusion: It is revealed from this study that patients treated with a combination of NB-UVB with topical Tacrolimus ointment (0.1%) showed better treatment outcome, more effective and becomes a new mode of treatment. Journal of Armed Forces Medical College Bangladesh Vol.13(1) 2017: 86-89

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EFFICACY AND SAFETY OF TACROLIMUS OINTMENT COMPARED WITH THAT OF HYDROCORTISONE ACETATE OINTMENT IN CHILDREN WITH ATOPIC DERMATITIS

PEDIATRICS ◽

10.1542/peds.112.s2.461b ◽

2003 ◽

Vol 112 (Supplement_2) ◽

pp. 461-462

Author(s):

Stacie M. Jones

Keyword(s):

Atopic Dermatitis ◽

Efficacy And Safety ◽

Hydrocortisone Acetate ◽

Tacrolimus Ointment

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Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis

Journal of Allergy and Clinical Immunology ◽

10.1067/mai.2002.121831 ◽

2002 ◽

Vol 109 (3) ◽

pp. 539-546 ◽

Cited By ~ 144

Author(s):

Sakari Reitamo ◽

Edwin J.M. Van Leent ◽

Vincent Ho ◽

John Harper ◽

Thomas Ruzicka ◽

...

Keyword(s):

Atopic Dermatitis ◽

Efficacy And Safety ◽

Hydrocortisone Acetate ◽

Tacrolimus Ointment

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Topical Application of Tacrolimus Ointment Did Not Alter the Cutaneous Pigmentation of Yucatan Micropigs

International Journal of Toxicology ◽

10.1080/109158199225765 ◽

1999 ◽

Vol 18 (1) ◽

pp. 19-22 ◽

Cited By ~ 3

Author(s):

Ihor Bekersky ◽

Garry Boswell ◽

Kaname Ohara ◽

Yoshio Kuroda ◽

Christopher Sambuco

Keyword(s):

Topical Application ◽

Test Site ◽

Positive Control ◽

Negative Control ◽

Application Site ◽

Miniature Swine ◽

Tacrolimus Ointment ◽

Topical Tacrolimus ◽

All Trans Retinoic Acid ◽

Liver And Kidney

Tacrolimus is a potent immunosuppressant marketed for the prevention of rejection in liver and kidney transplantation. Topical tacrolimus has been shown to be effective in the treatment of atopic dermatitis, a disease with an immunologic basis, and is currently being developed for this indication. The objective of the current study was to determine whether repeated topical application of tacrolimus ointment could result in hypopigmentation at the application site(s). Each of 10 Yucatan miniature pigs received topical application of 0.03%, 0.1%, and 0.3% tacrolimus ointment, positive control (a combination of 2% 4-hydroxyanisole and 0.01% all-trans-retinoic acid, 4-HAArRA), and a negative control (vehicle placebo) to five test sites (approximately 12.5 cm2) along either side of the dorsal midline (10 sites per animal). Tacrolimus and controls were randomly assigned to the test site on each animal and were applied unoccluded twice daily for 8 weeks at a dose volume of 0.1 ml per site for tacrolimus and vehicle control and 0.025 ml per site for the positive control. Topical application of tacrolimus ointment in concentrations of up to 0.3% for 8 weeks had no effect on the cutaneous pigmentation of Yucatan miniature swine. In contrast, the application of 4-HAArRA produced a statistically significant (P<.05) induction of hypopigmentation from week 4 through the end of the study application.

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Safety and Efficacy of Tacrolimus Ointment 0.1% (Protopic™) in Atopic Dermatitis: A Canadian Open-Label Multicenter Study

Journal of Cutaneous Medicine and Surgery ◽

10.1177/120347540400800402 ◽

2004 ◽

Vol 8 (4) ◽

pp. 213-219 ◽

Cited By ~ 4

Author(s):

Jerry Tan ◽

Richard Langley

Keyword(s):

Atopic Dermatitis ◽

Severe Disease ◽

Multicenter Trial ◽

Application Site ◽

Skin Infections ◽

Open Label ◽

Safety And Efficacy ◽

Topical Tacrolimus ◽

Efficacy Parameters ◽

Study Sites

Background: Most previously published trials of topical tacrolimus in atopic dermatitis were of relatively short duration and comprised a limited population with moderate-to-severe disease. Objective: The goal of the study was to evaluate the safety and efficacy over a 6-month period of tacrolimus 0.1% ointment in children and adults with a broader severity spectrum of atopic dermatitis. Methods: An open-label multicenter trial in patients 2 years and older was used. Primary safety and tolerability assessments included skin infection and application site adverse events. Efficacy parameters were body surface area involvement, pruritus score, and overall reponse. Results: There were 240 patients recruited at 23 study sites. Significant improvement from baseline was noted for all efficacy endpoints in both pediatric and adult patients. Skin infections occurred in 26% of patients. Burning sensation with product application, reported by 38% of patients, was transient and of mild-to-moderate severity in the majority. Conclusion: Tacrolimus 0.1% ointment was safe, well tolerated, and efficacious in treatment of atopic dermatitis in children and adults over six months.

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Effect of topical tacrolimus ointment on SCORAD index in pediatric atopic dermatitis.

The Professional Medical Journal ◽

10.29309/tpmj/2020.27.11.4456 ◽

2020 ◽

Vol 27 (11) ◽

pp. 2414-2418

Author(s):

Shazia Bano ◽

Munazzah Meraj ◽

Rao Irfan

Keyword(s):

Atopic Dermatitis ◽

Clinical Signs ◽

Case Series ◽

Systemic Review ◽

Female Ratio ◽

Tacrolimus Ointment ◽

Topical Tacrolimus ◽

Case Series Study ◽

Co Morbidity ◽

Morbidity Data

Objectives: To determine topical tacrolimus ointment’s efficacy in atopic dermatitis. Study Design: Descriptive case series study. Setting: Outpatient Department of Dermatology, Liaquat University of Medical and Health Sciences (LUMHS), Civil Hospital, Hyderabad. Period: 12 October 2017 to 12 April 2018. Material & Methods: Consisted of 106 patients. Detailed History was taken from patients and systemic review was also done to assessed any co-morbidity. Data was analyzed through SPSS version 23.0. Results: In this study 71 (66.98%) patients were men and 35 (33.01%) were female; with male to female ratio 2:1. The mean age was 6.1+1.8 years. Clinical signs of patients were erythema 88(83.01%), edema 76(71.69%), Oozing/ crusting 45(42.45%), excoriation 59(55.66%) and lichenification 64(60.37%). Before treatment start the SCORAD index (SCORAD I) mean was 61.8 ± 11.12 (range 7–103): moderate cases were observed in 87(82.07%) patients (SCORAD I 30 – 49) and 19(17.92%) patients had severe AD (SCORAD I ≥50). After treatment, the SCORAD index mean was 35.8 ± 13.15 (range 7–103): 57(53.77%) patients had SCORAD index values ≤30; moderate cases (SCORAD I 30-49) were observed in 42(39.62%) patients and 7(6.60%) patients had severe AD (SCORAD I >50). In 57(53.77%) cases topical tacrolimus ointment (0.1%) showed positive efficacy in atopic dermatitis, while in 49(46.22%) cases observed negative. Conclusion: The application of topical tacrolimus ointment (0.1%) is effective in the treatment of atopic dermatitis in children.

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