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Clinical Trials/CTRI/2020/03/023725
CTRI/2020/03/023725CompletedPhase 1

Evaluation of skin sensitization potential of test product by Human Repeat Insult Patch Test (HRIPT). - None

The Himalaya Drug Company0 sites200 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Phase 1
Status
Completed
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

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