Trial Outcomes & Findings for A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion (NCT NCT04006795)

Last Updated: 2021-08-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Day 40

Results posted on

2021-08-13

Participant Flow

Participants were recruited from one center in Brazil.

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.

Participant milestones

Participant milestones
Measure	Overall Participants All participants in 3 week induction phase topically applied 2 semiocclusive patch (0.02milliliters per centimeter square\[mL/cm\^2\])on Monday, containing developmental serum,lotion,cream,negative control(Sodium Chloride\[NaCl:0.9percent{%}\])at 2sites on dorsum for 24hours.Post patch removal(Tuesday)sites cleaned,developmental serum reapplied,1site irradiated with 2.5Joules per centimeters square(J/cm\^2)ultraviolet(UV)A radiation,then with 0.3minimal erythemal doses(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 24hour on Friday.Participants then entered 2week rest phase(no product or patch applications) followed by challenge phase where all participants applied 2semiocclusive patches at 2naive sites for 24hours,1site irradiated(like induction phase).Assessment done after 24,48,72 hours of irradiation till Day40.
Induction Phase STARTED	37
Induction Phase COMPLETED	37
Induction Phase NOT COMPLETED	0
Rest Phase STARTED	37
Rest Phase COMPLETED	37
Rest Phase NOT COMPLETED	0
Challenge Phase STARTED	37
Challenge Phase COMPLETED	37
Challenge Phase NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=37 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.
Age, Continuous	41.6 Years STANDARD_DEVIATION 14.41 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Fitzpatrick Skin Type Grading Fitzpatrick Skin Type Grading	37 Number of Participants n=5 Participants
Fitzpatrick Skin Type Grading I - Pale white skin	0 Number of Participants n=5 Participants
Fitzpatrick Skin Type Grading II - White skin	5 Number of Participants n=5 Participants
Fitzpatrick Skin Type Grading III - Light brown skin	20 Number of Participants n=5 Participants
Fitzpatrick Skin Type Grading IV - Moderate brown skin	12 Number of Participants n=5 Participants
Fitzpatrick Skin Type Grading V - Dark brown skin	0 Number of Participants n=5 Participants
Fitzpatrick Skin Type Grading VI - Deeply pigmented dark brown to black skin	0 Number of Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 40

Population: The Safety Population included all randomized participants who received at least 1 dose of any study product.

Outcome measures

Outcome measures
Measure	Developmental Serum n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental serum (0.02 mL/cm\^2) in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental serum was re-applied and 1 of the 2 sites were irradiated with 2.5 J/cm\^2 UV A radiation,then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.	Developmental Lotion n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental lotion (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental lotion was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.	Developmental Cream n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental cream (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental cream was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.	Negative Control n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing 0.9 percent normal saline (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, normal saline was re-applied and 1 of the 2 sites was irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.
Percentage of Participants With Photo-initiated Potential Sensitization Reaction	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 40

Population: The Safety Population included all randomized participants who received at least 1 dose of any study product.

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.

Outcome measures

Outcome measures
Measure	Developmental Serum n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental serum (0.02 mL/cm\^2) in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental serum was re-applied and 1 of the 2 sites were irradiated with 2.5 J/cm\^2 UV A radiation,then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.	Developmental Lotion n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental lotion (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental lotion was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.	Developmental Cream n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental cream (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental cream was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.	Negative Control n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing 0.9 percent normal saline (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, normal saline was re-applied and 1 of the 2 sites was irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.
Percentage of Participants With a Photo-initiated Reaction (Score of '+' or Greater) Which is Not Considered Potential Sensitization Reaction	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 40

Population: The Safety Population included all randomized participants who received at least 1 dose of any study product.

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.

Outcome measures

Outcome measures
Measure	Developmental Serum n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental serum (0.02 mL/cm\^2) in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental serum was re-applied and 1 of the 2 sites were irradiated with 2.5 J/cm\^2 UV A radiation,then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.	Developmental Lotion n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental lotion (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental lotion was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.	Developmental Cream n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing developmental cream (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites were cleaned, developmental cream was re-applied and 1 of the 2 sites were irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites were assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.	Negative Control n=37 Participants All participants in induction phase were topically applied 2 semi-occlusive patch (Monday) containing 0.9 percent normal saline (0.02mL/cm\^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, normal saline was re-applied and 1 of the 2 sites was irradiated with 2.5J/cm\^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants were applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site was irradiated (same as induction phase). Assessment was done after 24, 48 and 72 hours of irradiation till day 40.
Percentage of Participants With a Potential Sensitization Reaction Which is Not Considered Photo-initiated	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 40

Population: The Safety Population included all randomized participants who received at least 1 dose of any study product.

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.