Evaluation of skin irritation and skin sensitization, hypo-allergenic potential of Test Product(Sunscreen) using Human Repeat Insult Patch Test (HRIPT).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Evaluation of cutaneous tolerance by dermatological scoring.
Study Overview
Brief Summary
Topical exposure to chemicals can lead to adverse skin effects or skin intolerances.
While some chemicals will only trigger an irritant response after repeated exposure of the same
skin area, other chemicals will even after a one-time exposure cause irritation.
HRIPT is a standard test; usually performed to check the tolerance of a product on skin after
repeated application of those products on the same site.
Sensitization is the process by which a person becomes, over time, increasingly allergic to a
substance through repeated exposure to that substance. It is very different from irritation
because it involves immune response, the reaction becomes worse with repeated exposure, and
it is usually specific to individuals. The HRIPT consists of 2 phases, possibly 3.
Phase I is the Induction Phase where product is applied to the skin 9 times over duration of 3
weeks. This is a followed by rest period of 10- 14 days after which the skin is exposed to the
product again in Phase II or the Elicitation Phase. A response in Phase II is usually allergic in
nature. In some cases when reactions at challenge are weak or do not follow a consistent
pattern, it may be necessary to conduct additional studies on a participant to determine if the
responses are indicative of allergy. This is Phase III of the study- Rechallenge Phase. A
Rechallenge may also be performed to verify that the response is persistent.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Voluntary men and/or women between 18 and 65 years with 50 participants having sensitive skin as determined by lactic acid sting test.
- •Photo type III (Tans after initial burn), IV (Burns minimally, tans easily) and V(Rarely burns, tans darkly easily).
- •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.
- •Willing to give written informed consent to participate in the trial after informing all information concerning the trial procedures and trial objectives.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the trial.
- •Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna...), during the course of the trial.
- •Should be able to read and write (in English, Hindi, or local language).
- •Having valid proof of identity and age.
Exclusion Criteria
- •Pregnancy (by UPT) and lactating women.
- •Scars, excessive terminal hair, or tattoo on the studied area.
- •A participant who the Investigator feels will not be compliant with trial requirements
- •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 trial procedures.
- •Chronic illness which may influence the outcome of the trial.
- •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).
- •Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Outcomes
Primary Outcomes
Evaluation of cutaneous tolerance by dermatological scoring.
Time Frame: Visit 1: ICD and inclusion or exclusion. | Induction Phase: Patch application on Visit 1 (V1, V3,V5, V7, V9, V11, V13, V15, V17). | Patch will be removed on Visit 2 (V2, V4, V6, V8, V10, V12,V14, V16, V18). | Patch area will be clinically examined, graded and scored on Visit 3 (V3, V5, V7, V9, V11, V13, V15, V17, V19) | Challenge Phase: Patch application will be on naïve sites on the back on V20; | patch will be removed at V21 (24 hours).Scoring on V22 (48 hours), V23 (72 hours). V24 (96 hours).
Secondary Outcomes
No secondary outcomes reported