Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Evaluation of skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale.
Study Overview
Brief Summary
Patch test - This test is performed to assess the dermal safety of test product involved in the
study. It is a technique used to determine the potential of specific substances to cause irritancy
of the skin. Irritants are substances that damage the skin by direct toxic action. The damage
will depend upon the nature of the irritant, its concentration, and duration of exposure.
Irritation is manifested as inflammatory responses such as erythema (redness), oedema
(swelling), vesiculation and finally to an intense suppurative reaction without the involvement
of immune system.
In general, patches are applied for a contact period of 24 hours, and skin reaction is assessed
under a constant artificial daylight source and the marked site is scored post 24 hours after the
removal of the patches. Reactions such as erythema, dryness and wrinkling are scored on a 0
– 4-point scale and oedema is scored on another 0 – 4-point scale (Draize scale).
Result: The study was completed and there were no adverse events reported.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Voluntary men and women (preferably equal number of males and females) between 18 and 65 years.
- •Photo type III to V.
- •Having apparently healthy skin on test area.
- •For whom the Investigator considers that the compliance will be correct.
- •Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •Having signed a Consent Form.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna...), during the course of the study.
- •Should be able to read and write (in English, Hindi or local language).
- •10.Having valid proof of identity and age.
Exclusion Criteria
- •Pregnancy (by history) and lactating women.
- •Scars, excessive terminal hair or tattoo on the studied area.
- •Dermatological infection/pathology on the level of studied area.
- •Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
- •Any clinically significant systemic or cutaneous disease, which may interfere with study procedures.
- •Chronic illness which may influence the outcome of the study.
- •Participants on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month).
- •Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Outcomes
Primary Outcomes
Evaluation of skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale.
Time Frame: 48 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Rajiv Joshi
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.)