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

NCT04007159 | Completed Results

• 1 other identifier: 212383
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Care

Keywords

Skin Care, Cosmetic Facial Product

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants With a Positive Reaction Score (Score of '+' or Greater) as Assessed by a Trained Evaluator

  Day 40

Study Arms (4)

Developmental Serum

EXPERIMENTAL

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

Developmental Lotion

EXPERIMENTAL

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

Developmental Cream

EXPERIMENTAL

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

Negative Control

PLACEBO COMPARATOR

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

Interventions

Serum OTHER

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)

Developmental Serum

Lotion OTHER

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)

Developmental Lotion

Cream OTHER

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)

Developmental Cream

Normal Saline OTHER

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)

Negative Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Campinas, São Paulo, 13084-791, Brazil

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The human repeated insult patch test (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.

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: August 30, 2019
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• 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.

Locations

BR (1)