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To check the safety of the products

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041621
Enrollment
100
Registered
2022-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

None listed

Interventions

Route of administration- Topical
Duration: 3 weeks for each subject Intervention2: 2.RM.M480.77: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 3 weeks for each subject Intervention3: 3.RM.M480.74: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 3 weeks for each subject Intervention4: 4.RM.M480.76: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 3 weeks for each subject Intervention5: 5.RM.M480.70: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 3 weeks for each subject Intervention6: 6.RM.M480.81: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 3 weeks for each subject Intervention7: 7.RM.M480.85: 40 µl of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Micr
Duration: 3 weeks for each subject Intervention8: 8.RM.M480.86: 40 µl of investigational product with or without dilution (as per the protocol) wil

Sponsors

Marico Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects 18 to 65 years of age 2. Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator. 3. The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment. 4. Subjects with skin type (Normal: Oily: Combination: Dry in the ratio of 1:1:1:1), and sensitive skin (dry sensitive skin: normal sensitive skin in the ration 1:1) 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 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 10. Subjects with skin photo type III to V

Exclusion criteria

Exclusion criteria: 1. Pregnant women/ Nursing mothers 2. Scars excessive terminal hair or tattoo on the studied area. 3. Henna tattoo anywhere on the body (in case of studies involving hair dyes). 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 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

Design outcomes

Primary

MeasureTime frame
To evaluate the dermatological safety of the investigational products on healthy human subjectsTimepoint: Approximately 6 weeks for each subject

Secondary

MeasureTime frame
NoneTimepoint: NA

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt Ltd

ritambhara@mscr.in08041125934

Outcome results

None listed

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