Health Condition 1: null- Subjects showing symptoms of Miliaria rubra or Miliaria crystallina
Conditions
Interventions
Intervention1: P1080: Amount: Covering the affected area. Frequency: Twice Daily for two weeks. Total Duration of therapy: 6 weeks.
Intervention2:
Sponsors
ITC Limited Peenya Industrial Area Peenya Bangalore
Eligibility
Inclusion criteria
Inclusion criteria: 1. 70 volunteers of either gender in age group of 5 to 50 years. At least 10 volunteers in each of the following age brackets: (i) 5-10 yrs, (ii) 11-17 yrs (iii) 18-50 yrs. 2. Volunteers with primary symptoms of Miliaria rubra on either of back/forearm/neck/ shoulder/chest/underarm/forehead or more than one of these. 3. Volunteers with no history of having used a similar product during or since 1 week prior to the scheduled study commencement. 4. Volunteers who show no skin sensitivity symptoms to the investigational products during skin sensitivity test. 5. Female volunteers who are neither pregnant nor nursing. 6. Volunteers who are willing to abstain from using any product other than the provided cleanser and test product during the study period. 7. Volunteers willing to visit the site at specified frequencies for periodic evaluations. 8. Volunteers willing to comply with study specific requirements. 9. Volunteers willing to give a written informed consent and come for regular observation.
Exclusion criteria
Exclusion criteria: 1. Volunteers with symptoms of Miliaria pustulosa, Miliaria profunda as identified by the dermatologist. 2. Volunteers who have participated in similar kind of investigation in the past four weeks. 3. Volunteers having infections on skin/ nail that could spread or interfere with the test readings. 4. Volunteers with a known history or current condition of allergy or sensitivity to cosmetic products/ fragrances 5. Volunteers on medications (e.g. steroids or antihistamines) that could compromise the study. 6. Volunteers who are undergoing any medical treatment or taking any systemic medicines since 4 weeks prior to study commencement or applying any topical medication within 2 weeks prior to study commencement which could compromise the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of the test product in alleviating the symptoms of Miliaria in comparison to baseline and the reference productTimepoint: week1, week 2, week 3, week 4, week 5, week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| the efficacy of the test products in preventing the occurrence of Miliaria in comparison to the untreated control site and the reference productTimepoint: Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | — |
Countries
India
Contacts
Public ContactMs Vaishali Dhavan
Scientist
Outcome results
None listed