Skin CareNCT04007159
To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products
A study testing Serum, Lotion and Cream in people with Skin Care, run by GlaxoSmithKline at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Serum, Lotion and Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Aug 2019to 29 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
A randomized, single blind (evaluator), single-center, Human Repeat Insult Patch Test (HRIPT) study in healthy adult participants aged 18 to 65 years to evaluate the cutaneous irritation and contact sensitization potential of 3 cosmetic facial skincare products. The participants will undergo repeated cutaneous application of semi-occlusive patch of 3 cosmetic facial skincare products and a reference product as a negative control (saline solution). HRIPT is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions. Screening of the participants will be performed at Visit 1 (i.e. from Day 0 to Day 14). The study will progress in 3-phases: Induction phase, Rest Phase and Challenge Phase. The Induction phase will continue for 3 consecutive weeks (Visit 2 to Visit 10); at visit 2, the area for patch application will be designated between the scapula and waistline, away from the spinal mid-line. A controlled amount (0.02 milliliters per centimeters square [mL/cm^2]) of each study product will be randomly assigned within the patch system of each participant into the appropriate separate cell (3 cells for each of the test products and 1 cell for the saline solution). Each patch will remain in place for 48 (± 4) hours on weekdays and 72 (± 4) hours on weekend. Induction phase will be followed by 2-week (Visit 11) Rest phase; where there will be no product or patch applications. Rest phase is further followed by Challenge phase at week 6 (Visit 12 to Visit 15) in which a naïve area of the skin will be selected and a new patch with each of the cells filled with study products will be applied. After 48 (±4) hours of patch application, participants will return to the site, the patch will be removed, and subsequent test-site evaluations will be performed.
- Conditions
- Skin Care
- Being tested
- Serum, Lotion, Cream, Normal Saline
- Keywords
- Skin Care, Cosmetic Facial Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerumOther
Participants will be topically applied serum to the dorsum, under a semi-occlusive patch (0.02 milliliters per centimeters square [mL/cm^2] of serum in an individual cell of patch)
LotionOther
Participants will be topically applied lotion to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of lotion in an individual cell of patch)
CreamOther
Participants will be topically applied cream to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of cream in an individual cell of patch)
Normal SalineOther
Participants will be topically applied normal saline to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of normal saline in an individual cell of patch)
| Study group | Role | What they receive |
|---|---|---|
| Developmental Serum | Experimental | The participants will be applied a semi-occlusive adhesive patch containing the developmental serum (0.02 milliliters per centimeters square [mL/cm^2] in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase. Receives: Other: Serum |
| Developmental Lotion | Experimental | The participants will be applied a semi-occlusive adhesive patch containing the developmental lotion (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase. Receives: Other: Lotion |
| Developmental Cream | Experimental | The participants will be applied a semi-occlusive adhesive patch containing the developmental cream (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase. Receives: Other: Cream |
| Negative Control | Placebo comparator | The participants will be applied a semi-occlusive adhesive patch containing the 0.9 percent (%) normal saline (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40
Human repeated insult patch test (HRIPT) reactions as per (ICDRG) were scored by trained blind evualuator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment of positive reactions was determined by the blinded dermatologist and reported as Yes/ No/ Unable to determine. Percentage of participants with potential sensitization (count of "Yes"/ total reactions) were reported in form of numbers in this outcome measure.
Measured: Day 40
Secondary outcomes (1)
Percentage of Participants With a Positive Reaction Score (Score of '+' or Greater) as Assessed by a Trained Evaluator
HRIPT reactions as per ICDRG were scored by trained blind evaluator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment was determined by the blinded dermatologist and reported as a score of '+' or greater. Percentage of participants with any positive reaction (a score of '+' or greater) will be reported in numbers in this outcome measure.
Measured: Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start30 Aug 2019
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin CareStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The human repeated insult patch test (HRIPT) is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007159
- Sponsor's protocol ID
- 212383
- Status last verified
- Nov 2020
- First submitted
- 1 Jul 2019
- Last updated
- 10 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04007159
- Acronym / sponsor ID
- 212383
- Conditions
- Skin Care
- Keywords
- Skin Care, Cosmetic Facial Product
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized, single blind (evaluator), single-center, Human Repeat Insult Patch Test (HRIPT) study in healthy adult participants aged 18 to 65 years to evaluate the cutaneous irritation and contact sensitization potential of 3 cosmetic facial skincare products. The participants will undergo repeated cutaneous application of semi-occlusive patch of 3 cosmetic facial skincare products and a reference product as a negative control (saline solution). HRIPT is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions. Screening of the participants will be performed at Visit 1 (i.e. from Day 0 to Day 14). The study will progress in 3-phases: Induction phase, Rest Phase and Challenge Phase. The Induction phase will continue for 3 consecutive weeks (Visit 2 to Visit 10); at visit 2, the area for patch application will be designated between the scapula and waistline, away from the spinal mid-line. A controlled amount (0.02 milliliters per centimeters square [mL/cm^2]) of each study product will be randomly assigned within the patch system of each participant into the appropriate separate cell (3 cells for each of the test products and 1 cell for the saline solution). Each patch will remain in place for 48 (± 4) hours on weekdays and 72 (± 4) hours on weekend. Induction phase will be followed by 2-week (Visit 11) Rest phase; where there will be no product or patch applications. Rest phase is further followed by Challenge phase at week 6 (Visit 12 to Visit 15) in which a naïve area of the skin will be selected and a new patch with each of the cells filled with study products will be applied. After 48 (±4) hours of patch application, participants will return to the site, the patch will be removed, and subsequent test-site evaluations will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The human repeated insult patch test (HRIPT) is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions.
| Arm | Type | Receives |
|---|---|---|
| Developmental Serum | Experimental | Other: SerumThe participants will be applied a semi-occlusive adhesive patch containing the developmental serum (0.02 milliliters per centimeters square [mL/cm^2] in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase. |
| Developmental Lotion | Experimental | Other: LotionThe participants will be applied a semi-occlusive adhesive patch containing the developmental lotion (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase. |
| Developmental Cream | Experimental | Other: CreamThe participants will be applied a semi-occlusive adhesive patch containing the developmental cream (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase. |
| Negative Control | Placebo comparator | Other: Normal SalineThe participants will be applied a semi-occlusive adhesive patch containing the 0.9 percent (%) normal saline (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerumParticipants will be topically applied serum to the dorsum, under a semi-occlusive patch (0.02 milliliters per centimeters square [mL/cm^2] of serum in an individual cell of patch) | Other | Developmental Serum |
| LotionParticipants will be topically applied lotion to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of lotion in an individual cell of patch) | Other | Developmental Lotion |
| CreamParticipants will be topically applied cream to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of cream in an individual cell of patch) | Other | Developmental Cream |
| Normal SalineParticipants will be topically applied normal saline to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of normal saline in an individual cell of patch) | Other | Negative Control |
Primary outcome
Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40
Time frame: Day 40
Human repeated insult patch test (HRIPT) reactions as per (ICDRG) were scored by trained blind evualuator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment of positive reactions was determined by the blinded dermatologist and reported as Yes/ No/ Unable to determine. Percentage of participants with potential sensitization (count of "Yes"/ total reactions) were reported in form of numbers in this outcome measure.
1 secondary outcome
Percentage of Participants With a Positive Reaction Score (Score of '+' or Greater) as Assessed by a Trained Evaluator
Time frame: Day 40
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum, Lotion and Cream in people with Skin Care, run by GlaxoSmithKline at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40 (time frame: Day 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.