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To study the safety of a test product on humans

Evaluation of Skin Safety of a test product using 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Participants with Normal Skin. IS 4011:2018 Guidelines - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057315
Enrollment
26
Registered
2023-09-06
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: DRDC/2023/024: Approximately 0.04 gm ‘DRDC/2023/024’ will be filled in wells of patch chamber and applied on back/upper arm of participant.Patches will be secured using micropore tape.

Sponsors

Dabur Research and Development Centre.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Voluntary men and women (preferably equal number of males and females) between 18 and 65 years. 2. Fitzpatrick skin type III to IV. 3. Having apparently healthy skin on test area. 4. Willingness to discontinue the use of cleansing and/or cosmetic products in the application areas during the course of the trial, 5. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 6. Willing to give written informed consent to participate in the trial after informing all information concerning the trial procedures and trial objectives. 7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the trial. 8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna…), during the course of the trial. 9. Should be able to read and write (in English, Hindi, or local language). 10. Ready to wear loose cotton clothes 11. Having valid proof of identity and age. 12. Subject having not participated in another trial in the past one month.

Exclusion criteria

Exclusion criteria: 1. Pregnancy (by UPT) and lactating women. 2. Scars, excessive terminal hair, or tattoo on the studied area. 3. A participant who the Investigator feels will not be compliant with trial requirements 4. Dermatological infection/pathology on the level of studied area. 5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye). 6. Any clinically significant systemic or cutaneous disease, which may interfere with trial procedures. 7. Chronic illness which may influence the outcome of the trial. 8. Participants on any medical treatment either systemic or topical which may interfere with the performance of the trial (presently or in the past 1 month). 9. Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.

Design outcomes

Primary

MeasureTime frame
Evaluation of cutaneous tolerance of skin reactions.Timepoint: 48 hours

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactMs Preetha Paul

C.L.A.I.M.S. Pvt. Ltd.

preetha@claimsclinical.com66758851

Outcome results

None listed

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