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Evalution of loofah and scrub pad on healthy human subjects

Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/012250
Enrollment
72
Registered
2018-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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.LDPE Based loofah,2.LDPE Based bar loofah,3..Scrub pad.: Dose: In case of LDPE Loofah, 5ml of shower gel is dispensed on the moist loofah and spread across the body. In case of LDPE B

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.Nearly equal representation of all skin types â?? Normal, Dry, Oily, Combination, Sensitive skin. 3.Female Volunteers who are neither pregnant nor nursing. 4.Volunteers having experienced a liquid bathing product in the past 6 months. 5.Volunteers who are willing to abstain from using any product other than the provided test products during the study period. 6.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 Dermatologist may 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 reactionsTimepoint: 14 days for each subject

Countries

India

Contacts

Public ContactRitambhara

MS Clinical Research Pvt Ltd

rachana.shilpakar@mscr.in08040917253

Outcome results

None listed

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