Skin Care
Conditions
Keywords
Skin Care, Cosmetic Facial Product
Brief 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).
Detailed description
A single-center, randomised, evaluator (single) blind study in healthy adult participants aged 18 to 65 years with no dermatological disorders to evaluate the cutaneous photo- irritation and photo-sensitisation potential of three cosmetic facial skincare products. During Screening (Visit 1), the participants will sign an informed consent, will undergo dermatological assessment to ensure they have no dermatoses on their dorsum that might impact their safety, Fitzpatrick Phototype of II to IV and colorimetry analysis of their skin type using the Individual Typology Angle, which will be used to estimate minimal erythemal dose (MED). At Visit 2, the eligible participants will undergo MED irradiation where the participant will be administered a series of 6 controlled doses of UV radiation. At Visit 3, the participants will undergo MED determination, where a trained evaluator will evaluate the exposed skin to determine the lowest dose of UV radiation required to induce uniform, unambiguous erythema for signs of visible erythema. Further, the study will progress in 3-phases: Induction phase, Rest Phase and Challenge Phase. The Induction phase (3 weeks: Visit 4 to Visit 18); at visit 4, the area for applying 2 consecutive patches will be designated between the scapula and waistline. A controlled amount (0.02 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). Every Monday, patch sites will be evaluated, 2 patches will be applied, post 24 hours (Tuesday) the patches will be removed, patch sites can be cleaned, patch sites will be evaluated, test products/ saline will be re-applied and 1 of the 2 sites will be irradiated with 2.5 Joules per centimetre square UVA radiation with a Schott UG11+WG335 filter (or equivalent) in place, and then with 0.3 MEDs of UVA+UVB radiation (filters UG11+WG320). The sites will be assessed immediately after irradiation and 24 hours post irradiation (Wednesday) and duplicate patches will be re-applied as applied on Monday. Same procedure will be repeated on Thursday as done on Tuesday and on Friday the patch sites will be evaluated. The same process will continue for 3 consecutive weeks. Then there will be 2 weeks of Rest phase; where there will be no product or patch applications. Rest phase is further followed by Challenge phase at week 6 (Visit 19 to Visit 23) where there will be a duplicate parallel series of product applications under semi-occlusive patches to 2 naïve areas on Monday. Post 24 hours (Tuesday) patches will be removed and 1 of the 2 sites will be irradiated similar as done in induction phase. The sites will be assessed immediately post irradiation and after 24 hours (Tuesday), 48 hours (Wednesday) and 72 hours (Thursday) of irradiation. At visit 23, after the challenge phase the final assessments will be performed by the dermatologist.
Interventions
OTHERSerum
Participants will be topically applied adhesive patch containing developmental serum
OTHERLotion
Participants will be topically applied adhesive patch containing developmental lotion
OTHERCream
Participants will be topically applied adhesive patch containing developmental cream
OTHERNormal Saline
Participants will be topically applied adhesive patch containing normal saline
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 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 (self-reported). * A participant who is breastfeeding. * A participant with known or suspected intolerance or hypersensitivity to the study materials/product (or closely related compounds) 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, f) engaging in activities that result in excessive sweating, and g) intentional exposure to artificial ultraviolet light or cosmetic procedures. * A participant with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema, psoriasis or skin cancer. * 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. 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 with history of diseases aggravated or triggered by ultraviolet radiation. * 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 (e.g. any photosensitising medication such as tetracycline, thiazides, fluoroquinolones, etc.) within one month prior to inclusion. * A participant who has used any of the following topical or systemic medications up to two weeks before the screening visit: immuno-suppressants, antihistamines, nonsteroidal anti-inflammatory drugs (NSAIDS), and particular aspirin (\>200mg/d), within two weeks prior to inclusion and/or corticosteroids. * 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. * Currently receiving allergy injections or received an allergy injection within 7 days prior to Visit 1 or expects to begin injections during study participation. * A participant with any skin marks on the back that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles, open sores, pimples, or cysts). * A participant that intends bathing (in the sea or a pool), using a sauna, or partaking in water sports, or activities that lead to intense sweating for the duration of the study. * A participant who has used a transcutaneous electrical nerve stimulation (TENS) machine 1 day before the screening visit or intends to use a TENS machine at any point during the study. * A participant with history of sensitisation in a previous patch study. * A participant with history of abnormal reaction to sun exposure. * A participant who had intense sunlight exposure or sun tanning sessions up to 30 days before the screening evaluation. * A participant with recent history (within the last 5 years) of alcohol or other substance abuse. * A participant who has previously been enrolled in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Photo-initiated Potential Sensitization Reaction | Day 40 | Scoring of patch test reactions was performed by blind evaluator as per International Contact Dermatitis Research Group (ICDRG) grading '- 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,vesicles); '+++':extreme positive reaction (bullous reaction, intense erythema and infiltration, coalescing vesicles).Score range '- to +++' where '-' indicated no adverse reaction and '+++' indicated very strong adverse reaction.Any positive reaction ('+' or greater):considered potential sensitization(PS) upon dermatologist discretion and as potential photo-initiated if a)positive reaction occur at ultraviolet (UV) exposed site,b)occur at both UV and non-UV sites with maximum score at UV exposed site being higher than non-UV exposed site.Percentage of participants with photo-initiated PS were reported in numbers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Photo-initiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction | Day 40 | Scoring of patch test reactions was performed by blind evaluator as per ICDRG grading '- 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, vesicles);'+++':extreme positive reaction (bullous reaction, intense erythema and infiltration, coalescing vesicles).Score range '- to +++' where '-' indicated no adverse reaction and '+++' indicated very strong adverse reaction.Any positive reaction ('+' or greater) was classified as photo-initiated if a) a positive reaction occurs only at UV exposed site,b) occur at both UV and non-UV site with maximum score at UV exposed site being higher than maximum score at non-UV exposed site. Percentage of participants with any photo-initiated reaction (score of '+' or greater) without potential sensitisation were reported in form of numbers. |
| Percentage of Participants With a Potential Sensitization Reaction Which is Not Considered Photo-initiated | Day 40 | Scoring of patch test reactions was performed by blind evaluator as per ICDRG grading grading '- 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 range '- to +++' where '-' indicates no adverse reaction and '+++' indicates very strong adverse reaction.Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion and was further considered as non-photoinitiated if: a positive reaction occurs only at the non-UV exposed site. Percentage of participants with any non-photoinitiated potential sensitisation was reported in form of numbers. |
| Percentage of Participants With a Non-photoinitiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction | Day 40 | Scoring of patch test reactions was performed by blind evaluator as per ICDRG grading grading '- 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 range '- to +++' where '-' indicates no adverse reaction and '+++' indicates very strong adverse reaction.Any positive reaction (a score of '+' or greater) was considered as non-photoinitiated if: a positive reaction occurs only at the non-UV exposed site. Percentage of participants with non-photoinitiated reaction (score of '+' or greater) without potential sensitization was reported in form of numbers. |
Countries
Brazil
Participant flow
Recruitment details
Participants were recruited from one center in Brazil.
Pre-assignment details
A total of 61 participants were screened, of which 40 participants were enrolled and 37 participants were randomized, 3 enrolled participants were not randomized as they missed scheduled site visits. All 37 randomized participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants All participants in 3 week induction phase topically applied 2 semiocclusive patch (0.02 mL/cm\^2)on Monday, containing developmental serum,lotion,cream,negative control(NaCl: 0.9 %)at 2 sites on dorsum for 24 hours.Post patch removal (Tuesday) sites cleaned,developmental serum reapplied,1 site irradiated with 2.5 J/cm\^2 UVA radiation,then with 0.3 MEDs of UVA+UVB radiation.Duplicate test site not exposed to UVradiation. 24hours post irradiation(Wednesday),sites assessed,duplicate patches applied as on Monday.Irradiation on Thursday similar to Tuesday,assessment post 24 hour on Friday.Participants then entered 2 week rest phase(no product or patch applications) followed by challenge phase where all participants applied 2 semiocclusive patches at 2 naive sites for 24 hours, 1 site irradiated(like induction phase).Assessment done after 24,48,72 hours of irradiation till Day 40. | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 41.6 Years STANDARD_DEVIATION 14.41 |
| Fitzpatrick Skin Type Grading Fitzpatrick Skin Type Grading | 37 Number of Participants |
| Fitzpatrick Skin Type Grading III - Light brown skin | 20 Number of Participants |
| Fitzpatrick Skin Type Grading II - White skin | 5 Number of Participants |
| Fitzpatrick Skin Type Grading I - Pale white skin | 0 Number of Participants |
| Fitzpatrick Skin Type Grading IV - Moderate brown skin | 12 Number of Participants |
| Fitzpatrick Skin Type Grading V - Dark brown skin | 0 Number of Participants |
| Fitzpatrick Skin Type Grading VI - Deeply pigmented dark brown to black skin | 0 Number of Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 8 / 37 | 8 / 37 | 8 / 37 | 8 / 37 | 8 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 |
Outcome results
Primary
Percentage of Participants With Photo-initiated Potential Sensitization Reaction
Scoring of patch test reactions was performed by blind evaluator as per International Contact Dermatitis Research Group (ICDRG) grading '- 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,vesicles); '+++':extreme positive reaction (bullous reaction, intense erythema and infiltration, coalescing vesicles).Score range '- to +++' where '-' indicated no adverse reaction and '+++' indicated very strong adverse reaction.Any positive reaction ('+' or greater):considered potential sensitization(PS) upon dermatologist discretion and as potential photo-initiated if a)positive reaction occur at ultraviolet (UV) exposed site,b)occur at both UV and non-UV sites with maximum score at UV exposed site being higher than non-UV exposed site.Percentage of participants with photo-initiated PS were reported in numbers.
Time frame: Day 40
Population: The Safety Population included all randomized participants who received at least 1 dose of any study product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Developmental Serum | Percentage of Participants With Photo-initiated Potential Sensitization Reaction | 0 Participants |
| Developmental Lotion | Percentage of Participants With Photo-initiated Potential Sensitization Reaction | 0 Participants |
| Developmental Cream | Percentage of Participants With Photo-initiated Potential Sensitization Reaction | 0 Participants |
| Negative Control | Percentage of Participants With Photo-initiated Potential Sensitization Reaction | 0 Participants |
Secondary
Percentage of Participants With a Non-photoinitiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction
Scoring of patch test reactions was performed by blind evaluator as per ICDRG grading grading '- 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 range '- to +++' where '-' indicates no adverse reaction and '+++' indicates very strong adverse reaction.Any positive reaction (a score of '+' or greater) was considered as non-photoinitiated if: a positive reaction occurs only at the non-UV exposed site. Percentage of participants with non-photoinitiated reaction (score of '+' or greater) without potential sensitization was reported in form of numbers.
Time frame: Day 40
Population: The Safety Population included all randomized participants who received at least 1 dose of any study product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Developmental Serum | Percentage of Participants With a Non-photoinitiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction | 0 Participants |
| Developmental Lotion | Percentage of Participants With a Non-photoinitiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction | 0 Participants |
| Developmental Cream | Percentage of Participants With a Non-photoinitiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction | 0 Participants |
| Negative Control | Percentage of Participants With a Non-photoinitiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction | 0 Participants |
Secondary
Percentage of Participants With a Photo-initiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction
Scoring of patch test reactions was performed by blind evaluator as per ICDRG grading '- 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, vesicles);'+++':extreme positive reaction (bullous reaction, intense erythema and infiltration, coalescing vesicles).Score range '- to +++' where '-' indicated no adverse reaction and '+++' indicated very strong adverse reaction.Any positive reaction ('+' or greater) was classified as photo-initiated if a) a positive reaction occurs only at UV exposed site,b) occur at both UV and non-UV site with maximum score at UV exposed site being higher than maximum score at non-UV exposed site. Percentage of participants with any photo-initiated reaction (score of '+' or greater) without potential sensitisation were reported in form of numbers.
Time frame: Day 40
Population: The Safety Population included all randomized participants who received at least 1 dose of any study product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Developmental Serum | Percentage of Participants With a Photo-initiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction | 0 Participants |
| Developmental Lotion | Percentage of Participants With a Photo-initiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction | 0 Participants |
| Developmental Cream | Percentage of Participants With a Photo-initiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction | 1 Participants |
| Negative Control | Percentage of Participants With a Photo-initiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction | 0 Participants |
Secondary
Percentage of Participants With a Potential Sensitization Reaction Which is Not Considered Photo-initiated
Scoring of patch test reactions was performed by blind evaluator as per ICDRG grading grading '- 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 range '- to +++' where '-' indicates no adverse reaction and '+++' indicates very strong adverse reaction.Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion and was further considered as non-photoinitiated if: a positive reaction occurs only at the non-UV exposed site. Percentage of participants with any non-photoinitiated potential sensitisation was reported in form of numbers.
Time frame: Day 40
Population: The Safety Population included all randomized participants who received at least 1 dose of any study product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Developmental Serum | Percentage of Participants With a Potential Sensitization Reaction Which is Not Considered Photo-initiated | 0 Participants |
| Developmental Lotion | Percentage of Participants With a Potential Sensitization Reaction Which is Not Considered Photo-initiated | 0 Participants |
| Developmental Cream | Percentage of Participants With a Potential Sensitization Reaction Which is Not Considered Photo-initiated | 0 Participants |
| Negative Control | Percentage of Participants With a Potential Sensitization Reaction Which is Not Considered Photo-initiated | 0 Participants |