Last updated: 06/03/2021 07:20:07
To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Human Repeat Insult Patch Test (HRIPT) in Healthy Subjects to Assess the Cutaneous Irritation and Sensitization Potential of Three Developmental Cosmetic Facial Products
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40
Timeframe: Day 40
Secondary outcomes:
Percentage of Participants With a Positive Reaction Score (Score of ‘+’ or Greater) as Assessed by a Trained Evaluator
Timeframe: Day 40
Interventions:
Enrollment:
302
Primary completion date:
2019-29-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2019 to November 2019
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
Yes
- 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 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.
Inclusion and exclusion 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 participant at undue risk.
- A participant who has used any of the following topical or systemic medications up to two weeks before the screening visit: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS, high dose aspirin), and/or corticosteroids.
- A participant who has used a transcutaneous electrical nerve stimulation (TENS) machine 1 day before the screening visit.
- A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
- A participant who has been vaccinated up to 1 month before the screening visit or is intending to receive a vaccination during their participation in the study.
- A participant with any skin marks on the back that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, open sores, pimples, cysts, vascular malformations, scars, tattoos, excessive hair, numerous freckles).
- A participant that intends bathing (in the sea or a pool), using sauna, or partaking in water sports, or activities that lead to intense sweating.
- A participant that is a prisoner or involuntary incarcerated.
- A participant from an indigenous tribe.
- A participant who has previously been enrolled in this study.
Trial location(s)
Location
GSK Investigational Site
Campinas, São Paulo, Brazil, 13084-791
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2019-29-11
Actual study completion date
2019-29-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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