A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion (NCT04006795) | Clinical Trial Compass
CompletedNot Applicable
A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion
Brazil40 participantsStarted 2019-08-28
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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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 invol…
What they're measuring
1
Percentage of Participants With Photo-initiated Potential Sensitization Reaction