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Showing 7 results for Safety

Saman Ahmad Nasrollahi, Hurnaz Hassanzade, Taraneh Yazdanparast, Shadi Marami Zenouz, Mehdi Mohiti Asli, Alireza Firooz,
Volume 5, Issue 2 (7-2014)
Abstract

Background and Aim: Sunscreens are an important part of photoprotection strategy. They are exposed to strict safety evaluation using human subjects such as in vivo studies of skin irritation. Biophysical parameters measurements could be used as fast and noninvasive methods to measure any destructive effect of cosmetic formulations on skin application sites. Methods: Five sunscreens were selected from Iran's market to determine changes in Transepidermal Water Loss (TEWL), stratum corneum hydration, pH, melanin and hemoglobin contents by biometric assessments with MPA 580Cutometer®. Results: There was no significant change in skin pH, melanin and hemoglobin contents before and after sunscreen application. Significant change in TEWL and stratum corneum hydration after use of some sunscreens might be contributed by the occlusive and humectant ingredients which used in base cream. Conclusion: Application of the studied sunscreens on human volunteers has not shown any adverse effects and these formulations could be recommended to use.
Saman Ahmad Nasrollahi, Hurnaz Hassanzade, Taraneh Yazdanparast, Somayeh Yadangi, Shadi Marami Zonouz, Mehdi Mohiti Asli, Alireza Firooz,
Volume 5, Issue 3 (10-2014)
Abstract

Background and Aim: Moisturizers have important roles in the treatment of dry skin. Their safety has to be evaluated on human volunteers in order to assess their potential skin irritation. Measurements of skin biophysical parameters can be used as fast and noninvasive methods to assess any harmful effect of cosmetic formulations on the skin sites where those products are applied. Methods: Two moisturizers were selected from Iran's market to determine the changes in Trans Epidermal Water Loss (TEWL), stratum corneum hydration, pH, melanin and hemoglobin contents by biometric assessments with MPA 580 Cutometer®. Results: There was no any significant change in TEWL, skin pH, melanin and hemoglobin contents before and after products application. Stratum corneum hydration was increased after application of Neu Derm Renutrive Honey Shea from 0.09 to 0.39 (P0.001). Neu Derm Optimal Hydrosense increased stratum corneum hydration from 0.23 to 0.48 (P0.001). Conclusion: Application of the studied moisturizers on human volunteers did not show any adverse effect. So, those products could be recommended for safe use. Significant changes in the stratum corneum hydration associated with application of each moisturizer were related to humectant ingredients which were used in each product.
Aniseh Samadi, Saman Ahmad Nasrollahi, Alireza Firooz,
Volume 6, Issue 4 (1-2016)
Abstract

Background and Aim: Androgenetic alopecia (AGA) is the most common form of alopecia in men, worldwide and topical minoxidil appears to be the most effective and safe treatment for AGA beside oral finasteride. Safety assessment of topical minoxidil formulation could be conducted using in vivo studies on human volunteers. Using skin biophysical parameters is a fast and noninvasive method for safety assessment of topical products.

Methods: A topical combination of Minoxidil 5% solution in combination with chamomile extract from Iran’s pharmaceutical market tested on the skin of the forearm of 15 healthy volunteers. Changes in transepidermal water loss (TEWL), stratum corneum hydration, pH, melanin and hemoglobin contents have been evaluated, using biometric assessments with MPA 580 Cutometer®.

Results: There was not any significant change in skin hydration (P=0.692), TEWL (P=0.191), stratum corneum pH (P=0.613), melanin (P=0.533), and hemoglobin (P=0.579) contents before and after topical minoxidil application.

Conclusion: No significant change detected in skin erythema and assessed parameters Application of minoxidil 5% + chamomile 7% topical solution on human volunteers has not shown any adverse effects and these formulations could be recommended to use.


Setareh Ameri, Taraneh Yazdanparast, Saman Ahmad Nasrollahi,
Volume 7, Issue 2 (7-2016)
Abstract

Background and Aim: Dermatitis or eczema is an itchy skin disorder which is usually caused by the skin inflammatory reaction in response to combination of genetic and environmental factors. This study was aimed to assess the safety of anti-dermatitis creams and possible side effects on human volunteers through measuring the skin biophysical parameters with non-invasive methods.

Methods: Two groups of 15 adults and 15 children as healthy volunteers participated for safety assessment of three anti atopic and contact dermatitis creams. All measurements were done using Cutometer® MPA 580 and the changes in the rate of transepidermal water loss (TEWL), stratum corneum hydration, content of melanin and hemoglobin (erythema) and skin pH were recorded. The obtained data were analyzed using SPSS software version 20 and P<0.05 were considered as significant.

Results: In this trial, no statistically significant changes in skin biophysical parameters including TEWL, melanin, erythema and pH was observed. The stratum corneum hydration on the applicatioins areas of Dermalex Repair Eczema, Dermalex Repair Contact Eczema, Dermalex Repair Eczema for Babies & Children compared to the control sides were significantly different (P=0.002, 0.001 and 0.013). This significant difference was due to emollient or humectant compounds in these creams.

Conclusion: Because of no adverse changes in the skin biophysical parameters, the studied anti-dermatitis creams could be conisdered as safe products. In addition, due to self-assessment results of adverse effects by the participants, no significant adverse effect was seen.


Asra Asgharzadeh, Sima Marzban, Bahman Amani, Leyla Yavari,
Volume 8, Issue 1 (4-2017)
Abstract

Background and Aim: Microdermabrasion is a minimally invasive technology that is widely used in the field of cosmetic medicine. The mechanism of action of microdermabrasion is mechanical peeling of the skin using metal crystals. This review was conducted to evaluate the safety and efficacy of microdermabrasion in the treatment of scar, acne, striae and its other indications.

Methods: A comprehensive electronic search was done in clinical evidence databases for clinical trials, systematic reviews, health economic evaluations, and health technology studies. The databases and search engines were PubMed, Ovid Medline, Scopus, Turning Research into Practice (TRIP), Center for Reviews and Disseminations (CRD), Database of Abstracts of Reviews of Effects (DARE), National Health System Economic Evaluation Database (NHS EED), Health Technology Assessment (HTA), Cochrane Library, and ClinicalKey. The search was done up to July 2014. Key references were manually searched to find relevant studies. The eligible articles were investigated regarding the safety and efficacy of microdermabrasion.

Results: This systematic review includes 19 studies with a total of 368 patients, whom were treated with microdermabrasion for treatment of acne, vitiligo, melasma, acne scars, striae, skin rejuvenation, photo damaged skin and, photo-aging. Appraisal of the studies supported the efficacy and safety of microdermabrasion in treating the aforementioned skin problems.

Conclusion: Microdermabrasion, either as a single therapeutic intervention or in combination with other interventions, can be used in the treatment of several skin diseases and conditions. Since its side effects are milder than some other interventions, generally, it is considered as a safe method.


Amirhoushang Ehsani, Hasan Hajmohammadtaghiseyrafi, Pedram Nourmohammadpour, Mahdi Naghdipour, Mina Koohian Mohammadabadi, Ala Ehsani, Amirhossein Rahimnia,
Volume 14, Issue 1 (5-2023)
Abstract

Background and Aim: Lower limb telangiectasias are commonly seen in the general population and especially in females. This disorder not only causes cosmetic problems but also can cause pain and related problems of increased venous blood pressure. These varicose veins are one of the most common causes that patients refer to dermatology clinics. Considering some complications and limitations of sclerotherapy, we decided to investigate the efficacy and safety of the Long-Pulsed Nd:YAG 1064-nm laser as an alternative method.
 

Methods: 29 patients underwent at least three sessions of 1064 nm Nd: YAG laser treatment at intervals of 4 weeks. Before the first treatment session, after each session, and six months after the last session, photos were taken of the treatment site. Finally, clinical response and satisfaction rate with the treatment were recorded based on the score of a secondary dermatologist and the patient himself based on the improvement criteria from 0 to 4.
 

Results: According to the dermatologist's judgment, the average satisfaction with the treatment is 3.38 out of 4 with a standard deviation of 0.5, and based on the patient's assessment, it is 3.2 out of 4 with a standard deviation of 0.71, which is equivalent to more than 76% of the effectiveness of Nd:YAG 1064 nm laser in the treatment of telangiectatic veins. The pain during laser treatment was recorded as 6.27 with a standard deviation of 2.64 based on The VAS Scale.
 

Conclusion: Our experience has demonstrated that the long-pulsed 1064 nm Nd:YAG laser is an effective, reliable, safe method in the treatment of telangiectatic and reticular veins of the lower limbs with minimal side effects and complications.


Ala Ehsani, Amirhoushang Ehsani, Zahra Razavi, Mina Koohian Mohammadabadi, Mahshidsadat Ansari, Zeynab Aryanian, Pedram Nourmohammadpour, Amirmohammad Almasi, Amirhossein Rahimnia,
Volume 15, Issue 2 (8-2024)
Abstract

Background and aim: As the use of botulinum toxin to treat glabellar lines increases, particularly in Iran, where foreign products (e.g. Dysport) are relatively expensive, it becomes important to compare the efficacy, side effects, and duration of action of two locally produced botulinum toxin brands, Masport® and Dyston®. This study seeks to assess and compare the treatment results of these two medications.
 

Methods: In this cross-sectional, descriptive, retrospective study, the medical records of 81 patients who visited Razi Dermatology Hospital for the treatment of moderate to severe glabellar lines were reviewed. Data related to patient satisfaction, duration of action, and side effects of Masport® and Dyston® botulinum toxin were collected and analyzed via a questionnaire.
 

Results: The mean satisfaction score was 7 for the Dyston® group and 7.7 for the Masport® group, with no statistically significant difference between the two groups (P=0.142). Additionally, the mean duration of action was 3.5 months for Dyston® and 3.8 months for Masport®, with no significant difference observed. Headache was the most common side effect reported, with no other major adverse events noted. Furthermore, there was no statistically significant difference in the incidence of side effects between the two groups.
 

Conclusion: The findings of this study indicate that both Dyston® and Masport® have similar efficacy and safety profiles. The choice between them can be primarily based on cost and patient or physician preference rather than any significant therapeutic differences. Larger studies are recommended to further validate these findings.



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