Article Details


Safety and Efficacy Assessment of a Sanitary Pad Containing Potassium Alum in Comparison to Ordinary Pads: A Cross-Over Trial

[ Vol. 13 , Issue. 1 ]

Author(s):

Aniseh Samadi, Saman A. Nasrollahi, Mansour Shamsipour, Ali A. Akhlaghi, Akram M. Mohammadi and Alireza Firooz   Pages 52 - 57 ( 6 )

Abstract:


Background: The cutaneous effects and suitability of a sanitary pad have been studied globally. Potassium alum has been used in menstrual pads as an antiseptic, astringent, deodorizer and antiperspirants. The aim of this study is to assess safety and suitability of a sanitary pad containing potassium alum (test) in comparison of simple pads (control) on healthy women residing in Iran.

Methods: This was a phase III cross-over study design, conducted on 16 healthy women over the course of two menstrual periods. The levels of erythema, fissuring, edema and papule formation as well as burning, and itching sensations have been evaluated based on clinical observations and interviews. Measurement of pH and swabs for bacteria counting of vulvar skin were also performed. The subjects used one type of sanitary pad during their first menstrual period and then used the other type during their subsequent menstrual period. Then the evaluations were repeated and the subjects were asked to complete self-assessment questionnaires about product suitability.

Results: All the volunteers (age: 18-50, mean: 37.43) completed the study. No signs of irritation were found in the clinical observations or in the interviews for either product. No significant difference from baseline was found in the number of total bacteria for either product but the vulvar areas were significantly more acidic after using product with potassium alum. The majority of subjects preferred the sanitary pad with potassium alum (p-value = 0.0416).

Conclusion: Both types of sanitary pads used in this trial were same, however, the pad with Potassium alum was preferred by the participants for greater suitability.

Keywords:

Sanitary pad, clinical study, cutaneous effects, antiseptic, astringent, deodorizer, antiperspirant.

Affiliation:

Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Department of Research Methodology and Data Analysis, Institute for Environmental Research, Tehran University of Medical Sciences, Tehran, Department of Epidemiology and Reproductive Health at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran

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