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To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products | Clinical Trials | Clareo Health

COMPLETEDNA

To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products

A Human Repeat Insult Patch Test (HRIPT) in Healthy Subjects to Assess the Cutaneous Irritation and Sensitization Potential of Three Developmental Cosmetic Facial Products

NCT04007159•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The aim of this study is to assess irritant or allergic response of 3 developmental cosmetic facial products following a conventional human repeated insult patch test methodology for 6 weeks.

Detailed Description

A randomized, single blind (evaluator), single-center, Human Repeat Insult Patch Test (HRIPT) study in healthy adult participants aged 18 to 65 years to evaluate the cutaneous irritation and contact sensitization potential of 3 cosmetic facial skincare products. The participants will undergo repeated cutaneous application of semi-occlusive patch of 3 cosmetic facial skincare products and a reference product as a negative control (saline solution). HRIPT is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions. Screening of the participants will be performed at Visit 1 (i.e. from Day 0 to Day 14). The study will progress in 3-phases: Induction phase, Rest Phase and Challenge Phase. The Induction phase will continue for 3 consecutive weeks (Visit 2 to Visit 10); at visit 2, the area for patch application will be designated between the scapula and waistline, away from the spinal mid-line. A controlled amount (0.02 milliliters per centimeters square \[mL/cm\^2\]) of each study product will be randomly assigned within the patch system of each participant into the appropriate separate cell (3 cells for each of the test products and 1 cell for the saline solution). Each patch will remain in place for 48 (± 4) hours on weekdays and 72 (± 4) hours on weekend. Induction phase will be followed by 2-week (Visit 11) Rest phase; where there will be no product or patch applications. Rest phase is further followed by Challenge phase at week 6 (Visit 12 to Visit 15) in which a naïve area of the skin will be selected and a new patch with each of the cells filled with study products will be applied. After 48 (±4) hours of patch application, participants will return to the site, the patch will be removed, and subsequent test-site evaluations will be performed.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant provision of a signed and dated in-formed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
•A participant who is willing and able to comply with scheduled visits, treatment plan, and study procedures.
•A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, with no clinically significant or relevant abnormalities in medical history or upon dermal examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
•A participant with Fitzpatrick phototype I to IV.
•A participant with healthy, intact skin at the proposed test area dorsum (below the shoulder, above the waist), as evaluated by a dermatologist, to ensure participant is free of clinically relevant dermatological conditions.

Exclusion Criteria

•A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
•A participant who has participated in other studies involving investigational product(s) within 30 Days prior to study entry and/or during study participation.
•A participant who has participated in other studies including non-medicinal, cosmetic studies within 7 Days prior to study entry and/or during study participation.
•A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
•A participant who is pregnant or intends to be-come pregnant during the study duration (self-reported).
•A participant who is breastfeeding.
•A participant with known or suspected intolerance or hypersensitivity to the study materials/product (or closely related com-pounds) or any of their stated ingredients, to hypoallergenic tape, or to the cotton patches.
•A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
•A participant unwilling or unable to comply with the Lifestyle Considerations; a) applying other product to test site, using cosmetics, b) changing dietary habits, c) getting patch test site wet, d) removing the patch, e) wearing tight or restrictive clothing that can remove patch, and f) engaging in activities that result in excessive sweating.
•A participant with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema.
+14 more criteria

Locations (1)

GSK Investigational Site

Campinas, São Paulo, Brazil

Key Dates

Start Date

August 30, 2019

Primary Completion Date

November 29, 2019

Completion Date

November 29, 2019

Last Updated

December 10, 2020

Enrollment

302

ACTUAL participants

Conditions

Skin Care

Interventions

Serum

OTHER

Lotion

OTHER

Cream

OTHER

Normal Saline

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products

Inclusion Criteria

Exclusion Criteria

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