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A study to check whether the test products are safe for use in human participants

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110082
Enrollment
24
Registered
2026-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

None listed

Interventions

Intervention1: Aqua Pump - 10% Niacinamide Face Serum (30ml): 40 microlitres of investigational product with or without dilution (as per the protocol) will be applied to the back side of the subject

Sponsors

Derma Goodness Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Trial participants in age group 18 - 65 years (both the ages inclusive). 2. Healthy male & female trial participants with skin types as defined in the population details under appendix. 3. Trial participants in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data. 4. Trial participant able to read, understand and sign an appropriate informed consent form indicating their willingness to participate. 5. Trial participants willing to maintain the patch test in position for 24 hours. 6. Trial participants willing to come for regular follow-up visits. 7. Trial participants ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: 1. Trial participants with infection or any skin indications at the test area i.e. back of the trial participants. 2. Trial participants with known history of skin allergy, antecedents or atopic trial participants. 3. Athletes and trial participants with history of excessive sweating. 4. Trial participants with cutaneous disease which may influence the study result. 5. Trial participants on oral corticosteroid. 6. Trial participants participating in any other cosmetic or therapeutic trial. 7. Trial participants who are pregnant or nursing (self-declared). 8. Trial participants with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. 9. Trial participants working with MSCR.

Design outcomes

Primary

MeasureTime frame
To determine the potential irritation of the test formulation on different skin types in a PIPT test.Timepoint: 0 hrs, 24 hrs and Day 7

Secondary

MeasureTime frame
NONETimepoint: NONE

Countries

India

Contacts

Public ContactRadha S

MS Clinical Research Pvt. Ltd

ritambhara@msclinical.com9945952952

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026