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

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.

Study Overview

• Status: Completed
• Conditions: Skin Care
• Intervention / Treatment: Other: Serum; Other: Lotion; Other: Cream; Other: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil, 13084-791
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
• A participant with any history of significant diseases or medical conditions known to alter skin appearance or physiologic response (e.g. uncontrolled diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
• A participant considered immune-compromised.
• A participant with active dermatosis (local or disseminated) that might interfere with the results of the study.
• A participant currently using any medication which in the opinion of the investigator, may affect the evaluation of the investigational product or place the participant at undue risk.
• A participant who has used any of the following topical or systemic medications up to two weeks before the screening visit: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS, high dose aspirin), and/or corticosteroids.
• A participant who has used a transcutaneous electrical nerve stimulation (TENS) machine 1 day before the screening visit.
• A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
• A participant who has been vaccinated up to 1 month before the screening visit or is intending to receive a vaccination during their participation in the study.
• A participant with any skin marks on the back that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, open sores, pimples, cysts, vascular malformations, scars, tattoos, excessive hair, numerous freckles).
• A participant that intends bathing (in the sea or a pool), using sauna, or partaking in water sports, or activities that lead to intense sweating.
• A participant that is a prisoner or involuntary incarcerated.
• A participant from an indigenous tribe.
• A participant who has previously been enrolled in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Developmental Serum; The participants will be applied a semi-occlusive adhesive patch containing the developmental serum (0.02 milliliters per centimeters square [mL/cm^2] in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.	Other: Serum; Participants will be topically applied serum to the dorsum, under a semi-occlusive patch (0.02 milliliters per centimeters square [mL/cm^2] of serum in an individual cell of patch)
Experimental: Developmental Lotion; The participants will be applied a semi-occlusive adhesive patch containing the developmental lotion (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.	Other: Lotion; Participants will be topically applied lotion to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of lotion in an individual cell of patch)
Experimental: Developmental Cream; The participants will be applied a semi-occlusive adhesive patch containing the developmental cream (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.	Other: Cream; Participants will be topically applied cream to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of cream in an individual cell of patch)
Placebo Comparator: Negative Control; The participants will be applied a semi-occlusive adhesive patch containing the 0.9 percent (%) normal saline (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.	Other: Normal Saline; Participants will be topically applied normal saline to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of normal saline in an individual cell of patch)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40	Human repeated insult patch test (HRIPT) reactions as per (ICDRG) were scored by trained blind evualuator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment of positive reactions was determined by the blinded dermatologist and reported as Yes/ No/ Unable to determine. Percentage of participants with potential sensitization (count of "Yes"/ total reactions) were reported in form of numbers in this outcome measure.	Day 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Positive Reaction Score (Score of '+' or Greater) as Assessed by a Trained Evaluator	HRIPT reactions as per ICDRG were scored by trained blind evaluator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment was determined by the blinded dermatologist and reported as a score of '+' or greater. Percentage of participants with any positive reaction (a score of '+' or greater) will be reported in numbers in this outcome measure.	Day 40

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Actual): November 29, 2019
• Study Completion (Actual): November 29, 2019

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Skin Care, Cosmetic Facial Product
• Other Study ID Numbers: 212383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No