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Evaluation of Safety & Efficacy of Bath Accessories

Dermatological Evaluation of Safety & Efficacy of Bath Accessories On Healthy Human Subjects - NIL

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012306
Enrollment
72
Registered
2018-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: 1.Bath Sponge, 2.Konjac Sponge, 3.Shower Tool : Dose:Adequate amount of the shower gel is to be dispensed on moist bath accessory and spread across the body parts to generate lather f

Sponsors

ITC Life Sciences Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and female volunteers in the age group of 18 to 50 years. 2.A total of 48 Male and 24 Female subjects. 3.Nearly equal representation of all skin typesââ?¬â?? Normal, Dry, Oily, Combination, Sensitive skin. 4.Female Volunteers who are neither pregnant nor nursing. 5.Volunteers having experienced a liquid bathing product in the past 6 months. 6.Volunteers who are willing to abstain from using any product other than the provided test products during the study period. 7.Volunteers willing to give a written informed consent.

Exclusion criteria

Exclusion criteria: 1.Volunteers with an active skin disorder or a significant history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of the Principle Investigator or Dermatologistmay affect the test results. 2.Volunteers whose skin has been excessively exposed to Sun or UV rays during the previous month in the opinion of the Investigator. 3.Volunteers with a known history or current condition of allergy or sensitivity to cosmetic products/fragrances. 4.Volunteers on undergoing any medical treatment or taking any systemic medicines since or taking steroids or antihistamines or medicines for chronic medical conditions or applying any topical medication that could compromise the study. 5.Female volunteers who are currently pregnant or breastfeeding. 6.Volunteers participating in any other cosmetics or any other clinical trial

Design outcomes

Primary

MeasureTime frame
Dermatological safety of the test products in comparison to baseline with regular usage of the test product with no significant skin irritation.Timepoint: 14 days for each subject

Secondary

MeasureTime frame
Efficacy of the investigational products in comparison to baseline in terms of improvement of skin condition with no significant skin reactions. Timepoint: 14 days for each subject

Countries

India

Contacts

Public ContactRitambhara

MS Clinical Research Pvt Ltd

sapna.r@mscr.in08040917253

Outcome results

None listed

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