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Evaluation of safety and efficacy of product

Evaluation of the safety and efficacy of Roll-on in terms of sweat, malodor, pigmentation reduction and improvement in moisturisation - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063817
Enrollment
40
Registered
2024-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Roll on: Product A: Shake the bottle well. Swipe the roll on back and forth until covered the surface of your underarm with a thin layer of deodorant. The test product will be applied o

Sponsors

ITC LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 2)Between 18 and 45 years of age. 3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) Specific criteria 4)Having mild to moderate malodour. 5)Having sweat and visible underarm pigmentation 6)Having shaved under arms two days before each study visit. 7)Having mild to moderate axillary odour and whose left vs right axillary odour levels are more or less the same. 8)Should use the clenser (mild, non-scented) exclusively provided at T-7 days during T-7 to T+14 days. 9)At T0 visit sweat collection has to be between 0.1 gm to 0.7 gm in each underarm, if the values are out of this range, the consumer should not be enrolled in the study.

Exclusion criteria

Exclusion criteria: )For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2) Having refused to give her 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. 6) Being epileptic. 7) Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8) Having cutaneous hypersensitivity 9) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 11) 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 is paracetamol) and/or smoked in the two hours preceding the measurements 12) Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13) Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 14) Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted)

Design outcomes

Primary

MeasureTime frame
The objective of this study will be to evaluate and compare the in vivo safety and efficacy of a Roll On in terms of reduction in sweat and malodour versus untreated control on healthy male and female subjects.Timepoint: Baseline, T Immediate (15 minutes after product application),T+15 days, T+16 days,T+17 days

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026