Comparison of Claro to Other Dermatological Devices for Acne Treatment

16 Pages·2008·1.99 MB·English

Comparison of Claro to Other Dermatological Devices for Acne Treatment

STUDY REPORT
GENERAL STUDY INFORMATION
Study Title: Custom Microbiology - Quantitative Assessment of Light Illumination on
Organism Reduction
Project Number: A06378
TRF Number: SPD01060908.CUST
TEST SUBSTANCE IDENTITY
Test Substance Name: Claro, Zeno, Tanda, Thermaclear and Evis Marvel-Mini
STUDY DATES
Date Sample Received: June 6,2008
Study Initiation Date: June 12,2008
Experimental Start Date: June 16, 2008
Experimental End Date: June 19, 2008
Study Completion Date: June 23, 2008
Test Organism ATCC # Growth Medium
Tryptic Soy Agar with 5% Sheep
Propionibacterium acnes 1 1827
Blood (BAP)
The microorganism used in this study was obtained from the American Type Culture Collection,
Manassas, Virginia.
Recovery Media
Agar Plate Medium: Tryptic Soy Agar with 5% Sheep Blood (BAP)
Test Exposure: 3secondsand 6seconds
Exposure Temperature: Room terr~perature( 23°C)
Soil Load Description: No organic soil load required
EXPERIMENTAL DESIGN
Duplicate suspensions of bacterial cells, contained within micro-titer wells, were exposed to each
test substance (device) for each exposure time. After exposure, each treated suspension was
assayed for survivors. Appropriate purity and untreated population controls were performed.
Percent and log reductions were determined as compared to the untreated population control.
STUDY RESULTS
TABLE 1: CONTROL RESULTS
The following results from controls confirmed study validity:
Results
Type of Control
Propionibacterium acnes (ATCC I1 827)
Purity Control Pure
TABLE 2: UNTREATED POPULATION CONTROL RESULTS
Test Organism: Propionibacteriuma cnes
DILUTION Replicate Well #I Replicate Well #2
Number of Survivors
o0
1 TNTC,TNTC TNTC,TNTC
lo-'
TlVTC ,TNTC TNTC,TNTC
o - ~
1 TNTC,TNTC TNTC,TNTC
1 TNTC,TNTC TNTC,TNTC
o4
1 181,157 TNTC,TNTC
o - ~
1 22,9 31,30
-
TNTC = Too Numerous To Count = > 300 colonies
TABLE 3: TEST RESULTS
0
Test Organism: Propionibacferium acnes
EXPOSURE TIME: 3 seconds EXPOSURE TIME: 6 seconds
DILUTION 1 1
Replicate Well #I Replicate Well #2 Replicate Well #I Replicate Well #2
Number of Survivors
10 ° TNTC,TNTC
1
lo-' TNTC,TNTC TNTC,TNTC TNTC ,TNTC TNTC,TNTC
lo-' TNTC,TNTC TNTC-TNTC TNTC.TNTC TNTC.TNTC
4
Test Organism: Propionibacterium acnes
EXPOSURE TIME: 3 seconds EXPOSURE TIME: 6 seconds
DILUTION I 1
Replicate Well #I Replicate Well #2 Replicate Well #I Replicate Well #2
Number of Survivors
I
10 ° TNTC,TNTC TNTC,TNTC TNTC,-TNTC TNTC,TNTC
TNTC = Too Numerous To Count = > 300 colonies
TABLE 3: TEST RESULTS (continued)
Test Substance: Tanda
Test Organism: Propionibacterium acnes
EXPOSURE TIME: 3 seconds EXPOSURE TIME: 6 seconds
DILUTION 1 1
Replicate Well #I Replicate Well #2 Replicate Well #I Replicate Well #2
Number of Survivors
1O 0 TNTC,TNTC TNTC,TNTC TNTC,TNTC TNTC,TNTC
10" TNTC,TNTC TNTC,TNTC TNTC,TNTC TNTC,TNTC
I
10.~ TNTC,TNTC TNTC,TNTC TNTC,TNTC TIVTC,TNTC
* T
Test Organism: Propionibacterium acnes
EXPOSURE TIME: 3 seconds EXPOSURE TIME: 6 seconds
I
1
Replicate Well #I Replicate Well #2 Replicate Well #I Replicate Well #2
Number of Survivors
10 ° TNTC,TNTC TNTC,TNTC TNTC,TNTC TNTC,TNTC
10" TNTC-TNTC TNTC.TNTC TNTC.TNTC TNTC-TNTC
ThlTC = Too Numerous To Count = > 300 colonies
TABLE 3: TEST RESULTS (continued)
Test Substance: Thermaclear
Test Organism: Propionibacterium acnes
EXPOSURE TIME: 3 seconds EXPOSURE TIME: 6 seconds
DILUTION I I
Replicate Well #I Replicate Well #2 Replicate WeH #I Replicate Well #2
Number of Survivors
1o 0 TNTC,TNTC TNTC,TNTC TNTC ,TIVTC TNTC,TNTC
TNTC = Too Numerous To Count = > 300 colonies
TABLE 4: CALCULATED DATA
Test Substance: Claro
Untreated
Average
Population Log10
Test Organism control Number of Number of Percent Log10
Time CF U lmL * Survivors sui,,ors Reduction Reduction
(CFUIm L)*
(Average
Loglo)
2.4 O7
Propionibacterium
acnes
6 seconds (7.38)
* colony forming units per mL of test mixture
Test Substance: Zeno
----l--
Average
Untreated
Average
Population Loglo
Test Organism Exposure Control Number of Number of Percent Loglo
Time CFUlmL* S U ~ ~ ~ V~O~~~S~ i~~Re~du~c tion Reduction
(CFU/mL)*
(Average
?-I
1
53.8 % 0.34
Propion~bacteriUm 3 seconds 2.4 x 10' 1.11 X 10' 7.045
acnes
6 seconds (7.38) 9.9x106 7.00 58.8 % 0.38
,
* colony forming units per mL of test mixture
r
Test Substance: Tanda
Average
Untreated
Average
Population Log10
Test Organism Exposure Control Number of Number of Percent Loglo
Time CFUlmL* Survivors Survivors Reduction Reduction
(CFU/mL)*
(Average
Logto)
3 seconds 2.4 x 1O 7
Propionibacferium
acnes
6 seconds
* colony forming units per mL of test mixture
TABLE 4: CALCULATED DATA (continued)
Test Substance: Thermaclear
Average
Average
Population Log10
Test Organism Exposure Control Number of Number of Percent Loglo
Time CFUImL* Survivors ~~~~i~~Re~du~ct ion Reduction
(C FU /mL)*
(Average
Loglo)
3 seconds 2.4 x lo7
Propionibacterium
acnes
6 seconds
* colony forming units per mL of test mixture
Test Substance: Evis Marvel- nini
Average
Untreated
Average
Population Log10
Test Organism Exposure Control Number of Number of Percent Log10
Time CFUImL* Survivors Survivors Reduction Reduction
(CFU1mL)x
(Average
Loglo)
3 seconds 2.4 x lo7
Propionibacterium
acnes
6 seconds
* colony forming units per mL of test mixture