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safety of the test product to be checked

Evaluation of skin sensitization potential of investigational products by Human Repeat Insult Patch Test (HRIPT) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059663
Enrollment
100
Registered
2023-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

None listed

Interventions

Intervention1: Facial Toner-PAL/VLTN-E/23-001: 40 microlitre of investigational product without dilution will be applied on the back of the subject. Dose- 40 microlitre. Route of administration- Topic

Sponsors

HNL Business Services India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects 18 to 65 years (both inclusive) of age. 2. Subjects with skin photo type III to V 3. Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator. 4. The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment. 5. Willingness to avoid UV exposure (sun or artificial UV) on the test sites during the course of the study. 6. Subjects must have clear back. They should not have any infection or allergy on the tested area. They should have healthy skin (Healthy skin is smooth, with no breaks in the surface. It is devoid of any rashes, scars, bumps etc.) on test area 7. Subjects should be cooperative, informed of the need and duration of the examination and ready to comply with the protocol procedures 8. Subjects having valid proof of identity and age. 9. Willingness to avoid excessive water contact (like swimming etc.) or activity which causes excessive sweating (like exercise, sauna, etc.) during the course of study

Exclusion criteria

Exclusion criteria: 1. Pregnant women/ Nursing mothers 2. Presence of scars, excessive terminal hair or tattoo on the studied area. 3. Henna tattoo seen on the test site of the body. 4. Dermatological infection/pathology on the level of studied area 5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 6. Any clinically significant systematic or cutaneous disease, which may interfere with study treatment or procedures, as evaluated by the study PI and co-PI. 7. Chronic illness which may influence the outcome of the study. 8. Subject on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month) 9. Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial. 10. Subjects having mole or hair on the back which may influence the study results as per the investigator and study coordinator decision 11. Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness

Design outcomes

Primary

MeasureTime frame
To evaluate the dermatological safety of the investigational products on healthy human subjectsTimepoint: Approximately 45 days for each subject

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable

Countries

India

Contacts

Public ContactNavya Annam

MS Clinical Research Pvt Ltd

navya.annam@msclinical.com08041125934

Outcome results

None listed

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