CTRI/2020/03/023725CompletedPhase 1
Evaluation of skin sensitization potential of test product by Human Repeat Insult Patch Test (HRIPT). - None
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- The Himalaya Drug Company
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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.Willingness to avoid UV exposure (sun or artificial UV) on the test sites during the course of the study.
- •5.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
- •6.Subjects should be cooperative, informed of the need and duration of the examination and ready to comply with the protocol procedures
- •7.Should be able to read and write in English, Hindi or any other local language.
- •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
- •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
Investigators
Similar Trials
Completed
Phase 1
To study the safety of test products on the skin.CTRI/2020/06/026085The Himalaya Drug Company200
Not yet recruiting
Not Applicable
Repeat patch test on Humans with Normal Skin Type.CTRI/2020/06/025777Dabur India Limited
Not yet recruiting
Unknown
Assessment of safety of productCTRI/2024/07/070485Saffron Naturele Products Pvt Ltd
Completed
Not Applicable
Human Repeat Insult Patch TestingCTRI/2019/09/021426The Himalaya Drug Company345
Completed
Not Applicable
To check the safety of the productsCTRI/2022/04/041621Marico Limited100
