N/A
N=37
A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion
Skin Care
Bottom Line
View on ClinicalTrials.gov: NCT04006795 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Percentage of Participants With Photo-initiated Potential Sensitization Reaction — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Serum (Other); Lotion (Other); Cream (Other); Normal Saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Photo-initiated Potential Sensitization Reaction |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With a Photo-initiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction |
0; 0; 1; 0 | — |
| SECONDARY Percentage of Participants With a Potential Sensitization Reaction Which is Not Considered Photo-initiated |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With a Non-photoinitiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction |
0; 0; 0; 0 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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.
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 (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.
- A participant currently using a
Data sourced from ClinicalTrials.gov (NCT04006795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.