Last updated: 09/12/2019 09:40:14
To assess the cutaneous Irritation and sensitization potential of a cosmetic facial product using a Human Repeat Insult Patch Test (HRIPT) in Healthy participants
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Human Repeat Insult Patch Test (HRIPT) in Healthy Subjects to Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product
Trial description: The objective of this clinical study is to assess the irritation and sensitisation potential of a cosmetic test product after repeated semi-occlusive patch applications to healthy human participants by following a conventional HRIPT methodology under supervision of a dermatologist.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction phase at Day 3
Timeframe: At Day 3
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction phase at Day 5
Timeframe: At Day 5
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction phase at Day 8
Timeframe: At Day 8
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction phase at Day 10
Timeframe: At Day 10
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction phase at Day 12
Timeframe: At Day 12
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction phase at Day 15
Timeframe: At Day 15
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction phase at Day 17
Timeframe: At Day 17
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction phase at Day 19
Timeframe: At Day 19
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge phase at Week 6 after 30 minutes (maximum 1 hour) post patch removal
Timeframe: At Week 6 after 30 minutes (maximum 1 hour) post patch removal
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge phase at Week 6 after 24 (±2) hours post patch removal
Timeframe: At Week 6 after 24 (±2) hours post patch removal
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge phase at 6 week 48 (±2) hours, post patch removal
Timeframe: At Week 6 after 48 (±2) hours post patch removal
Secondary outcomes:
Not applicable
Interventions:
Other: Facial micellar cleanser
Other: Saline Solution: Sodium Chloride (NaCl; 0.9%)
Enrollment:
272
Observational study model:
Not applicable
Primary completion date:
2017-19-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2017 to May 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
- Healthy, intact skin at the proposed application site; dorsum (scapular region)
- Clinical assessment for eligibility (at Visit 1 and Visit 2 – if not combined) by a dermatologist to ensure participant is free of clinically relevant dermatological conditions
- Fitzpatrick phototype I to IV
- Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits
Exclusion criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Any history of significant dermatological diseases or conditions 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
- Presence of open sores, pimples, or cysts at the application site
- Active dermatosis (local or disseminated) that might interfere with the results of the study
- Considered immune compromised
- History of diseases aggravated or triggered by ultraviolet radiation
- Participants with dermatographism
- Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the participant at undue risk
- Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit
- Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit
- Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit
- Currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation
- Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication
- Study participants with a history of allergy to the study material/product, hypoallergenic tape, or to the cotton patches
- History of sensitisation in a previous patch study
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Recent history (within the last 5 years) of alcohol or other substance abuse
- Intense sunlight exposure or sun tanning sessions up to 30 days before the Screening evaluation
- Intention of bathing (in the sea or a pool), sauna, water sports, or activities that lead to intense sweating
- Any participant who, in the judgment of the Investigator, should not participate in the study
- Any skin marks on the test site that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles)
- Prisoner or involuntary incarcerated participant
- Participant from an indigenous tribe
- An employee of the sponsor or the study site or members of their immediate family
Trial location(s)
Study documents
Clinical study report
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
Completed
Actual primary completion date
2017-19-05
Actual study completion date
2017-19-05
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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