Efficacy of Short Term Topical Malva Sylvestris L. Cream in Pediatric Patients with Atopic Dermatitis: A Randomized Double-Blind PlaceboControlled Clinical Trial

2020 ◽  
Vol 20 ◽  
Author(s):  
Mahshid Meysami ◽  
Mohammad Hashem Hashempur ◽  
Mohammad Kamalinejad ◽  
Majid Emtiazy
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Malva Sylvestris ◽  
Topical Cream ◽  
Traditional Persian Medicine ◽  
Dermatologic Disease

Background: Atopic dermatitis (AD) is a chronic inflammatory pruritic dermatologic disease in children. Malva sylvestris L. (M. sylvestris) is a medicinal plant which is used as a remedy for eczema in traditional Persian medicine. Previous studies have shown anti‐ulcerogenic and anti‐inflammatory activity of this plant. Objectives: We designed a clinical trial to evaluate efficacy of topical cream of M. sylvestris extract in management of children with AD. Methods: Fifty one children with AD were randomly enrolled in two arms of a randomized, double-blind, controlled clinical trial. They were treated by topical cream of M. sylvestris extract or placebo for a palm-sized surface (single fingertip unit, twice daily) for 4 weeks. The SCORing Atopic Dermatitis (SCORAD) score was set as the primary outcome measure. Results: There was a significant improvement in the severity of participants’ dermatitis regarding skin thickening score, redness score, and total SCORAD score of the M. sylvestris group as compared with the placebo group (P= 0.009, P=0.01, and P=0.03; respectively). Conclusion: According to the results of this clinical trial, it could be concluded that topical use of M. sylvestris extract cream was effective on the reduction of the AD symptoms in children.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals A novel hydrocortisone-ethanol gel ointment for treating atopic dermatitis (eczema) in children: A double blind, randomized, controlled clinical trial

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Dale Lawrence Pearlman
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Severe Atopic Dermatitis ◽  
Double Blind ◽  
Parental Concerns ◽  
Score Improvement ◽  
Long Time ◽  
Secondary Endpoints

Importance: Current treatments for moderate to severe atopic dermatitis (AD) in children are limited by incomplete efficacy, long time to benefit, and parental concerns about safety. This study evaluated a novel ointment for treating AD containing 0.83% hydrocortisone and 17% dispersed ethanol gel micro bubbles.  Observations:20 children with moderate to severe AD participated in a one-week double blind, randomized, and controlled clinical trial. They were randomly assigned to apply BID either an ointment with 1% hydrocortisone ointment (HC) or a novel ointment containing 1% hydrocortisone and dispersed ethanol gel droplets (HC-EG).   The primary endpoint was superiority of HC-EG over HC ointment in SCORAD score improvement during therapy. A secondary endpoint was improvement in pruritus score during therapy. Both the primary and secondary endpoints were reached in this study. SCORAD score improved 74% on average with HC-EG ointment vs 41% with HC ointment (p=.02). Pruritus score improved 68% on average with HC-EG ointment vs 37% with HC ointment (p=.009). No toxicity requiring stopping therapy was observed in either treatment group.  Conclusions and Relevance: Inthis small controlled study HC-EG ointment was superior to HC ointment both in improving visible rash and pruritus of AD. Parents felt HC-EG ointment was safe because it contains no prescription corticosteroids, prescription immunosuppressants, or antibiotics. Independent larger studies would be a next step in evaluating further this new way to treat AD. 

scholarly journals Effect of polymerized type I collagen in hyperinflammation of adult outpatients with symptomatic COVID-19: a double blind, randomised, placebo-controlled clinical trial.

2021 ◽  
Author(s):  
Silvia Mendez-Flores ◽  
Angel Alexis Priego-Ranero ◽  
Daniel Azamar-Llamas ◽  
Hector Olvera-Prado ◽  
Kenia Illian Rivas-Redondo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Oxygen Saturation ◽  
Primary Outcome ◽  
Type I Collagen ◽  
Ambient Air ◽  
Controlled Clinical Trial ◽  
Type I ◽  
Double Blind ◽  
Duration Of Symptoms

BACKGROUND Currently, therapeutic options for ambulatory COVID-19 patients are limited. OBJECTIVE To evaluate the safety, efficacy and effect of the intramuscular administration of polymerized type I collagen (PTIC) on hyperinflammation, oxygen saturation and symptom improvement in adult outpatients with symptomatic COVID-19. DESIGN Double-blind, randomised, placebo-controlled clinical trial of PTIC vs placebo. SETTING Single Third-level hospital in Mexico City (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran) PARTICIPANTS Eighty-nine adult participants with a confirmed COVID-19 diagnosis and symptom onset within the 7 days preceding recruitment were included from August 31, 2020 to November 7, 2020 and followed for 12 weeks. Final date of follow-up was February 4, 2021. INTERVENTIONS Patients were randomly assigned to receive either 1.5 ml of PTIC intramuscularly every 12 h for 3 days and then every 24 h for 4 days (n=45), or matching placebo (n=44). MAIN OUTCOMES AND MEASURES The primary outcome was a mean reduction of at least 50% in the level of IP-10 compared to baseline. The secondary outcomes were mean oxygen saturation >92% while breathing ambient air and duration of symptoms. RESULTS Of 89 patients who were randomised, 87 (97.8%) were included in an intention-to-treat analysis; 37 (41.6%) were male and mean age was 48.5+/-14.0 years. The IP-10 levels decreased 75% in the PTIC group and 40% in the placebo group vs baseline. The comparison between treatment vs placebo was also statistically significant (P=0.0047). The IL-8 (44%, P=0.045), M-CSF (25%, P=0.041) and IL-1Ra (36%, P=0.05) levels were also decreased in the PTIC group vs baseline. Mean oxygen saturation >92% was achieved by 40/44 (90%), 41/42 (98%) and 40/40 (100%) of participants that received PTIC at 8, 15 and 97 days of follow-up vs 29/43 (67%), 31/39 (80%) and 33/37 (89%) of patients treated with placebo (P=0.001). The unadjusted accelerated failure time model showed that patients treated with PTIC achieved the primary outcome 2.70-fold faster (P<0.0001) than placebo. In terms of risk, the group of patients treated with PTIC had a 63% lower risk of having a mean oxygen saturation <92% vs placebo (P<0.0001). Symptom duration in patients treated with PTIC was reduced by 6.1+/-3.2 days vs placebo. No differences in adverse effects were observed between the groups at 8, 15 and 97 days of follow-up. CONCLUSIONS In this study, treatment with PTIC down-regulated IP-10, IL-8, M-CSF and IL-Ra levels, which could explain the PTIC effect on the higher proportion of patients with mean oxygen saturation readings > 92% and a shorter duration of symptoms as compared to patients treated with placebo. Although results are encouraging, larger randomised trials are needed.

scholarly journals Randomized, double-blind, placebo-controlled clinical trial measuring the effect of a dietetic food on dermatologic scoring and pruritus in dogs with atopic dermatitis

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Miguel Sánchez de Santiago ◽  
José Luis González Arribas ◽  
Yolanda Moral Llamas ◽  
Iveta Becvarova ◽  
Hein Meyer
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Control Diet ◽  
Clinical Signs ◽  
Controlled Clinical Trial ◽  
Omega 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Study Results ◽  
Multimodal Management

Abstract Background Canine atopic dermatitis (AD) is a common condition that often requires multimodal therapy. Including a diet in the multimodal management of AD may reduce medication doses, saving pet owners money and reducing side effects. The objective of this randomized, double-blind, placebo-controlled clinical trial was to determine if a diet fortified in antioxidants, polyphenols, and omega-3 fatty acids can reduce the clinical signs of AD. Forty client-owned dogs with AD were enrolled in the study and assigned to either an enriched diet (diet B) or control diet (diet A) for 60-days. CADESI-4 index scores and owner-reported pruritus scores were measured periodically. Results Total CADESI-4 index scores for dogs eating diet B were lower on day 60 compared to baseline (P = 0.003). There was no statistical difference in scores for dogs eating diet A over a 60-day period. Diet B dogs had 25 and 49% reductions in CADESI-4 index scores on days 30 and 60, respectively (P = 0.0007) while diet A had no change over the study period. When comparing the percent change in owner-reported pruritus scores, diet B also performed better than diet A. By day 60, owners feeding diet B to their dogs reported a significant reduction (P < 0.0001) of 46.4% in itching, while those on diet A reported a 26.8% reduction, which was not statistically significant (P = 0.08). Conclusions These study results demonstrate feeding a diet enriched with ingredients to improve skin health and reduce inflammation improves the clinical signs of AD in dogs.

scholarly journals Efficacy of a probiotic supplement in patients with atopic dermatitis: a randomized, double-blind, placebo-controlled clinical trial

2021 ◽  
Vol 31 (2) ◽  
pp. 225-232
Author(s):  
Angela Michelotti ◽  
Enza Cestone ◽  
Ileana De Ponti ◽  
Silvana Giardina ◽  
Marta Pisati ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo
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