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N/A N=280 Randomized Single-blind Basic Science

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

Skin Care

Enrolled (actual)
280
Serious AEs
0.4%
Results posted
Dec 2020
Primary outcome: Primary: Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40 — 2; 1; 1; 0 Number of 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
Nov 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40
2; 1; 1; 0
SECONDARY
Percentage of Participants With a Positive Reaction Score (Score of '+' or Greater) as Assessed by a Trained Evaluator
4; 4; 4; 4; 1; 1

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.

Eligibility Criteria

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 p
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04007159). 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.

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