Trial Outcomes & Findings for Green Tea and Ultraviolet Light-induced Skin Damage (NCT NCT00134381)

Last Updated: 2017-09-06

Results Overview

The mean change in number of active caspase-3+ apoptotic keratinocytes between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

48 hrs

Results posted on

2017-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	EGCG in Acetone Vehicle (L Side: Active; R Side: Placebo) bilateral comparison Subjects randomized to this group received applications of EGCG to a test site on the left side of the body and placebo to a test site on the right side of the body.	EGCG in Acetone Vehicle (R Side: Active; L Side: Placebo) bilateral comparison Subjects randomized to this group received applications of EGCG to a test site on the right side of the body and placebo to a test site on the left side of the body.	Caffeine in Acetone Vehicle (L Side: Active; R Side: Placebo) bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the left side of the body and placebo to a test site on the right side of the body.	Caffeine in Acetone Vehicle (R Side: Active; L Side: Placebo) bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the right side of the body and placebo to a test site on the left side of the body.	Caffeine in Cream Vehicle (L Side: Active; R Side: Placebo) bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the left side of the body and placebo to a test site on the right side of the body.	Caffeine in Cream Vehicle (R Side: Active; L Side: Placebo) bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the right side of the body and placebo to a test site on the left side of the body.
Overall Study STARTED	1	2	1	2	31	31
Overall Study COMPLETED	1	2	1	2	31	29
Overall Study NOT COMPLETED	0	0	0	0	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Green Tea and Ultraviolet Light-induced Skin Damage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bilateral Comparison n=68 Participants In this bilateral comparison study, subjects were randomized to receive applications of green tea product or placebo to test sites on the left and right sides of the body.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	1 Participants n=5 Participants
Race (NIH/OMB) White	66 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
Region of Enrollment United States	68 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hrs

Population: Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.

Outcome measures

Outcome measures
Measure	EGCG in Acetone Vehicle n=3 Participants bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received EGCG) n=3 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Acetone Vehicle n=3 Participants bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received Caffeine) n=3 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Vehicle Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).	Placebo Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds	28.34 cells/mm Standard Error 18.51	13.05 cells/mm Standard Error 9.98	10.68 cells/mm Standard Error 3.61	32.60 cells/mm Standard Error 28.14	—	—

PRIMARY outcome

Timeframe: 48 hr

The mean change in number of apoptotic "sunburn" cells between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.

Outcome measures

Outcome measures
Measure	EGCG in Acetone Vehicle n=3 Participants bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received EGCG) n=3 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Acetone Vehicle n=3 Participants bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received Caffeine) n=3 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Vehicle Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).	Placebo Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Change in UVB-Induced Apoptotic "Sunburn" Cells by Green Tea Compounds	18.94 cells/mm Standard Error 8.18	14.79 cells/mm Standard Error 7.43	28.86 cells/mm Standard Error 8.00	43.62 cells/mm Standard Error 29.22	—	—

PRIMARY outcome

Timeframe: 48 hr

Population: Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).

The percentage of apoptotic "sunburn" cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.

Outcome measures

Outcome measures
Measure	EGCG in Acetone Vehicle n=20 Participants bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received EGCG) n=20 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Acetone Vehicle n=26 Participants bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received Caffeine) n=26 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Vehicle Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).	Placebo Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic "Sunburn" Cells	7.50 percentage of "sunburn" cells Standard Error 2.06	4.93 percentage of "sunburn" cells Standard Error 1.54	5.10 percentage of "sunburn" cells Standard Error 0.80	4.63 percentage of "sunburn" cells Standard Error 0.60	—	—

PRIMARY outcome

Timeframe: 48 hr

The percentage of caspase-3-positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.

Outcome measures

Outcome measures
Measure	EGCG in Acetone Vehicle n=20 Participants bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received EGCG) n=20 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Acetone Vehicle n=26 Participants bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received Caffeine) n=26 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Vehicle Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).	Placebo Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells	6.54 percentage of caspase-3-positive cells Standard Error 1.85	4.53 percentage of caspase-3-positive cells Standard Error 1.16	4.38 percentage of caspase-3-positive cells Standard Error 0.92	3.15 percentage of caspase-3-positive cells Standard Error 0.46	—	—

PRIMARY outcome

Timeframe: 48 hr

The percentage of phospho-p53 (Ser15) positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.

Outcome measures

Outcome measures
Measure	EGCG in Acetone Vehicle n=20 Participants bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received EGCG) n=20 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Acetone Vehicle n=26 Participants bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received Caffeine) n=26 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Vehicle Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).	Placebo Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells	13.03 percentage of p-p53 (Ser15) pos. cells Standard Error 2.40	13.46 percentage of p-p53 (Ser15) pos. cells Standard Error 2.47	15.98 percentage of p-p53 (Ser15) pos. cells Standard Error 2.17	15.15 percentage of p-p53 (Ser15) pos. cells Standard Error 2.57	—	—

SECONDARY outcome

Timeframe: 48 hrs

Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence \[no erythema\]; 1 = mild \[pink or light red color\]; 2 = moderate \[red color\]; 3 = severe \[very red or dark color\]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The mean scores at 48 hr were calculated.

Outcome measures

Outcome measures
Measure	EGCG in Acetone Vehicle n=3 Participants bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received EGCG) n=3 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Acetone Vehicle n=3 Participants bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received Caffeine) n=3 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Vehicle Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).	Placebo Cream (1.5 MED Group) bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Effect of Green Tea Compounds on UVB-Induced Erythema	1.33 units on a scale Standard Error 0.44	1 units on a scale Standard Error 0	1.17 units on a scale Standard Error 0.17	1.33 units on a scale Standard Error 0.44	—	—

SECONDARY outcome

Timeframe: 24 hr

Population: Sixty-two (62) subjects received caffeine on one test site and placebo on the other site after exposure to 0.5-1.5 times individual subjects' minimal erythema dose (MED) of UVB.

Outcome measures

Outcome measures
Measure	EGCG in Acetone Vehicle n=12 Participants bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received EGCG) n=12 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Acetone Vehicle n=21 Participants bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Placebo (Acetone Vehicle in Subjects Who Received Caffeine) n=21 Participants bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).	Caffeine in Vehicle Cream (1.5 MED Group) n=29 Participants bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).	Placebo Cream (1.5 MED Group) n=29 Participants bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
Effect of 4-6% Caffeine on UVB-Induced Erythema	0.18 units on a scale Standard Error 0.04	0.38 units on a scale Standard Error 0.05	0.66 units on a scale Standard Error 0.06	0.83 units on a scale Standard Error 0.05	1.14 units on a scale Standard Error 0.05	1.36 units on a scale Standard Error 0.05

Adverse Events

Bilateral Comparison

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bilateral Comparison n=68 participants at risk In this bilateral comparison study, subjects were randomized to receive applications of green tea product or placebo to test sites on the left and right sides of the body after exposure of the test sites to UVB.
Reproductive system and breast disorders menstrual cramps	1.5% 1/68 • Number of events 1
Gastrointestinal disorders nausea	1.5% 1/68 • Number of events 1
Skin and subcutaneous tissue disorders tenderness of right test site	1.5% 1/68 • Number of events 1
Infections and infestations superficial wound infection	1.5% 1/68 • Number of events 1
Nervous system disorders headache	1.5% 1/68 • Number of events 1
Infections and infestations tooth abscess	1.5% 1/68 • Number of events 1
Skin and subcutaneous tissue disorders accidental removal of a suture	1.5% 1/68 • Number of events 1
Skin and subcutaneous tissue disorders rash over adhesive area	1.5% 1/68 • Number of events 1

Additional Information

Dr M Magliocco

UMDNJ-Robert Wood Johnson Medical School

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place