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Clinical Trials/CTRI/2022/08/044882
CTRI/2022/08/044882CompletedUnknown

Dermatological safety evaluation of 18 Herbs Organics JOINT PAIN OIL by Primary IrritationPatch test within 24 hours application on all types of healthy human skin

Buy happy Marketing LLP1 site in 1 country24 target enrollmentStarted: August 24, 2022Last updated:
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Trial Snapshot

Phase
Unknown
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Number of subjects that showed no significant irritation.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

clinical study was initiated for estimation of the overall safety of test products by PIPT within 24hours of application on healthy skin types. 24 healthy female and male (1:1) subjects of age group35 to 60 Years have to be recruited. There are test products and one Negative control and Positivecontrol. There are 5 visits and the total duration of the study is 8 days. Subject’s Self-Assessmenton skin irritation (baseline assessment for burning, itching, and stinging).Dermatologist’s Visualassessment as per Draize scale scoring system (for Erythema and Oedema) will be done

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
35.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Healthy Men and women volunteers are chosen in ratio of 1:1 aged > 35 and < 60years.
  • •10% of the sample size, are chosen who report joint pains.
  • •2.Subjects who are willing to participate in the study and sign the informed consent document and comply with the trial procedure.
  • •3.Having healthy skin on test area as assessed by dermatological examination and don’t have history of allergy.
  • •4.Subjects who are compliant with the study.

Exclusion Criteria

  • •1.Pregnant/nursing mothers.
  • •2.Scars, excessive terminal hair, or tattoo on the studied area.
  • •3.Dermatological infection/pathology on level of studied area.
  • •4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) 5.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.

Outcomes

Primary Outcomes

Number of subjects that showed no significant irritation.

Time Frame: Day 0,1,2,3,4,5

Score of less than or equal to 2 on the Draize scale

Time Frame: Day 0,1,2,3,4,5

Secondary Outcomes

  • na(na)

Investigators

Sponsor Class
Other [Pvt Ltd]

Study Sites (1)

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