A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion

NCT04006795 | Completed Results

• 1 other identifier: 212378
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the absence of sensitisation and irritation potential of a product when applied to the skin and exposed to ultraviolet (UV) radiation. Photo-sensitisation potential will primarily be evaluated through a subsequent semi-occluded application and UV exposure (challenge phase) after a 2-week rest period. Photo-irritation potential will primarily be evaluated through the repeated occluded application and UV exposure of the study products over 3 weeks (induction phase).

Conditions

Skin Care

Keywords

Skin Care, Cosmetic Facial Product

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Photo-initiated Potential Sensitization Reaction

  Scoring of patch test reactions was performed by blind evaluator as per International Contact Dermatitis Research Group (ICDRG) grading '- 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,vesicles); '+++':extreme positive reaction (bullous reaction, intense erythema and infiltration, coalescing vesicles).Score range '- to +++' where '-' indicated no adverse reaction and '+++' indicated very strong adverse reaction.Any positive reaction ('+' or greater):considered potential sensitization(PS) upon dermatologist discretion and as potential photo-initiated if a)positive reaction occur at ultraviolet (UV) exposed site,b)occur at both UV and non-UV sites with maximum score at UV exposed site being higher than non-UV exposed site.Percentage of participants with photo-initiated PS were reported in numbers.

  Day 40

Secondary Outcomes (3)

• Percentage of Participants With a Photo-initiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction

  Day 40

• Percentage of Participants With a Potential Sensitization Reaction Which is Not Considered Photo-initiated

  Day 40

• Percentage of Participants With a Non-photoinitiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction

  Day 40

Study Arms (4)

Developmental Serum

EXPERIMENTAL

All participants in induction phase will be topically applied 2 semi-occlusive patch (Monday) containing developmental serum (0.02milliliters per centimeter square\[mL/cm\^2\] in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental serum will be re-applied and 1 of the 2 sites will be irradiated with 2.5 Joules per centimeters square(J/cm\^2) ultraviolet(UV) A radiation,then with 0.3 minimal erythemal doses(MEDs) of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants will be applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site will be irradiated (same as induction phase). Assessment will be after 24, 48 and 72 hours of irradiation

Other: Serum

Developmental Lotion

EXPERIMENTAL

All participants in induction phase will be topically applied 2 semi-occlusive patch (Monday) containing developmental lotion (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental lotion will be re-applied and 1 of the 2 sites will be irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants will be applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site will be irradiated (same as induction phase). Assessment will be after 24, 48 and 72 hours of irradiation

Other: Lotion

Developmental Cream

EXPERIMENTAL

All participants in induction phase will be topically applied 2 semi-occlusive patch (Monday) containing developmental cream (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental cream will be re-applied and 1 of the 2 sites will be irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants will be applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site will be irradiated (same as induction phase). Assessment will be after 24, 48 and 72 hours of irradiation

Other: Cream

Negative Control

PLACEBO COMPARATOR

All participants in induction phase will be topically applied 2 semi-occlusive patch (Monday) containing 0.9 percent normal saline (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, normal saline will be re-applied and 1 of the 2 sites will be irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants will be applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site will be irradiated (same as induction phase). Assessment will be after 24, 48 and 72 hours of irradiation

Other: Normal Saline

Interventions

Serum OTHER

Participants will be topically applied adhesive patch containing developmental serum

Developmental Serum

Lotion OTHER

Participants will be topically applied adhesive patch containing developmental lotion

Developmental Lotion

Cream OTHER

Participants will be topically applied adhesive patch containing developmental cream

Developmental Cream

Normal Saline OTHER

Participants will be topically applied adhesive patch containing normal saline

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 informed 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 other study procedures.
• A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, 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 II 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 (self-reported).
• A participant who is breastfeeding.
• A participant with known or suspected intolerance or hypersensitivity to the study materials/product (or closely related compounds) 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, f) engaging in activities that result in excessive sweating, and g) intentional exposure to artificial ultraviolet light or cosmetic procedures.
• A participant with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema, psoriasis or skin cancer.
• 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. 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 with history of diseases aggravated or triggered by ultraviolet radiation.

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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: August 28, 2019
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: August 13, 2021
• Results First Posted: November 2, 2020

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• 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)