Erythema, Pruritis of genital area skin. Diaper [napkin] dermatitis, Pruritus vulvae
Conditions
Interventions
Intervention 1: Intervention group will consume Ladycare® sanitary pad containing Potassium Alum during menstrual cycle. Intervention 2: Control group will consume simple Ladycare® sanitary pad durin
Intervention group will consume Ladycare® sanitary pad containing Potassium Alum during menstrual cycle
Control group will consume simple Ladycare® sanitary pad during menstrual cycle
Sponsors
Jahan Saderat Industrial Group
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Age between 18 and 50 2.History of regular menstrual cycles [21-35±) 3) days] over the last year 3.Good general health 4.Regular use of sanitary pads 5.Written Informed Consent to participate in the study according to the schedule. 6.Participant accepted to use only the assigned sanitary products for the study duration. Exclusion Criteria: 1.Use of any systemic medications for treating yeast, any medicated antipruritic or antifungal topical products to the genital area, and oral antibiotics within 2 weeks of baseline measurements 2.Pregnancy or planning to become pregnant during the study 3.Known allergy to sanitary pads, or to fragrances 4.Objective and/or subjective symptoms or positive culture results for bacterial vaginosis, yeast/Candida, or Trichomonasis 5.Study physician anticipated that continuance of the study would be inappropriate Withdrawal criteria: 1.shaving or using depilatories in the pubic region 2.applying personal or skin care products to the external genitalia and perineum 3.intercourse for 24 hours prior to scheduled clinical assessments 4.taking anti-inflammatory, antihistamine, or steroidal medications 5.participating in other clinical trials with similar products 6.severe side effects during the study 7.patient's non-compliance 8.using other sanitary pads during the study
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythema in genital region skin. Timepoint: Before intervention and 7th and 14th day of each menstrual cycle. Method of measurement: objective scoring.;Perspiration in geital region. Timepoint: 7th day of each menstrual cycle. Method of measurement: Questionnaire.;Fungi colony (CFU/ml). Timepoint: Before intervention and 7th and 14th day of each menstrual cycle. Method of measurement: culture. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total aerobic bacteria (CFU/ml). Timepoint: Before intervention and 7th and 14th day of each menstrual cycle. Method of measurement: culture.;PH. Timepoint: Before intervention and 7th and 14th day of each menstrual cycle. Method of measurement: pH meter.;Absorbency. Timepoint: 7th and 14th day of each menstrual cycle. Method of measurement: Questionnaire.;Dryness. Timepoint: 7th and 14th day of each menstrual cycle. Method of measurement: Questionnaire.;Softness. Timepoint: 7th and 14th day of each menstrual cycle. Method of measurement: Questionnaire.;Convenience. Timepoint: 7th and 14th day of each menstrual cycle. Method of measurement: Questionnaire.;Product satisfaction. Timepoint: 7th and 14th day of each menstrual cycle. Method of measurement: Questionnaire.;Fissuring. Timepoint: Before intervention and 7th and 14th day of each menstrual cycle. Method of measurement: Objective scoring.;Edema. Timepoint: Before intervention and 7th and 14th day of each menstrual cycle. Method of measurement: Objective scoring.;Papule. Timepoint: Before intervention and 7th and 14th day of each menstrual cycle. Method of measurement: Objective scoring.;Itching. Timepoint: Before intervention and 7th and 14th day of each menstrual cycle. Method of measurement: Questionnaire.;Burning. Timepoint: Before intervention and 7th and 14th day of each menstrual cycle. Method of measurement: Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Alireza Firooz
Center for Research & Training in Skin Diseases & Leprosy
Outcome results
None listed