To evaluate and compare the in-vivo safety and anti miliaria efficacy of test products on healthy human subjects of varied skin types.
- Registration Number
- CTRI/2018/05/013804
- Lead Sponsor
- ITC Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 102
1) Indian / Asian male and female subjects
2) Healthy subjects
3) Between 20 and 50 years of age.
4) Skin on the studied anatomic unit should free of eczema, wounds, cuts, bruises, inflammatory scar.
5) Subjects willing to abide by the study protocol and restrictions (refrain from using any product other than the provided Investigational Product (IP).
6) Subject who has primary symptoms of miliria rubra on either the neck, back or arms
7) Subjects who are not sensitive to the ingredients of the test product (As disclosed by the subjects or as observed during the Skin sensitivity test as per the below procedure).
1)For female, being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2) Having refused to give her/his assent by not signing the consent form
3) Taking part in another study liable to interfere with this study
4) Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
5) Having a progressive asthma (either under treatment or last fit in the last 2 years)
6) Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7) Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8) Being epileptic.
9) Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted isparacetamol)
10) Having cutaneous hypersensitivity.
11) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
12) Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
13) Having changed her/his cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
14) Having any genetic and endocrinal disorders as disclosed by volunteers.
15) Having infections on skin/ nail that could spread or interfere with the test readings.
16) Having a known history or current condition of allergy or sensitivity to cosmetic products/ fragrances
17) Having symptoms of Miliaria pustulosa, Miliaria profunda as identified by the dermatologist.
In the 6 previous months
18) Having started, changed or stopped a hormonal treatment (hormonal contraception, cyproterone acetate �)
19) Having taken an oral retinoid-based treatment
In the previous month
20) Having had a local benzoyl-peroxide-based treatment, Clindamycin, AHA or a local retinoid-based treatment
21) Having had an oral treatment with a base of cimetidine, zinc (zinc gluconate) or spironolactone
22) Subjects who have participated in similar kind of investigation in the past four weeks.
In the previous week
23) Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
24) Having used a similar product during or since 1 week prior to the scheduled study commencement.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method