Efficacy of poly-pore 145bp _ver080802_.doc

CUSTOM SOLUTIONS REPORT
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Project: Efficacy of Poly-Pore® 145BP in Reduction of P. Acnes Bacteria
Purpose: To compare the efficacy of benzoyl peroxide (BPO) entrapped in Poly-Pore to free benzoyl
peroxide in its ability to reduce P. acnes bacteria counts from a facial scrub.

Conclusion: The Poly-Pore Delivery System is effective at causing a significant reduction in P. acne
counts over a 14-day period and the study showed that 3.5 % BPO entrapped in Poly-Pore was as
effective as a control system that contained 10 % free BPO.
Background: Acne is a chronic inflammatory disease of the sebaceous hair follicles that can be triggered
by a variety of causes. It is known that one particular common skin bacteria, Propionibacterium acnes –
P. acnes, is responsible for inflammation of the skin follicle. In addition to the papules and pustules
resulting from inflammation, most acne suffers also have excessive skin sebum. The excess sebum not
only aggravates the condition but also leads to an undesirable shiny or greasy appearance.
One of the leading OTC and prescription treatments of acne employs benzoyl peroxide. Widely
recognized as one of the most effective treatments for mild to moderate acne conditions, BPO is thought
to function through a combination of antibacterial action to reduce the bacteria on the skin and as a
kerolytic agent, helping to promote the sloughing off of dead skin cells. Despite its effectiveness, use of
BPO in treating the increasing cases of adult acne has been muted. This, in part, is due to the lack of
cosmetic elegance when compared to less effective but widely used ingredients such as salicylic acid.
BPO's limited solubility in acceptable solvents leads to limited formulating latitude. In addition, since it is
a kerolytic agent, BPO can also be somewhat irritating. Still further BPO, like many acne treatments have
limited impact in addressing the excess sebum and resulting greasy appearance.
Poly-Pore 145BP, a BPO deliver system, was developed specifically to address the negative attributes of
benzoyl peroxide. Through its exceptional adsorbent capacity, Poly-Pore is able to adsorb excess sebum,
addressing the undesirable appearance. Since Poly-Pore 145BP is easily dispersible in gels, emulsions,
and even powders, the formula gains a greater measure of latitude when using the system - substantially
improving the elegance of final products. Previous studies have shown that BPO entrapped in Poly-Pore
slows down the rate of release of BPO from an o/w formulation in comparison to a formulation that
contains only BPO. (see Figure 1) While a lower release rate should reduce the irritation often associated
with BPO, a potential concern is that the active will lose its clinical efficacy due to a lower concentration
delivered to the skin. This study was designed to measure the efficacy of Poly-Pore 145BP in comparison
to a formulation containing only BPO.


5 % Free BPO
4 % Free BPO + 1% BPO in PPE
5% BPO in PPE
Benzoyl Peroxide Recovered (ppm)
Time (hours)
Study Protocol
This study was conducted by Hilltop Research, Inc. Eighteen (18) panelists were chosen with the criteria
that they be in range of 12 –55 years in age, forehead porphyrin fluorescence grade of 2 or greater and
gave a written informed consent to participate in the study. The subjects applied the assigned test articles
to the entire face two times daily for the duration of the study. The P. acnes scrubs took place at Day 0
(baseline), Day 1, Day 3, Day 5 and Day 14 and in all cases before the morning application of the test
articles. Nine of the subjects used the control formulation, containing 10% BPO and the other panelists
used a formulation that contained 3.5 % BPO entrapped in Poly-Pore - approximately 7.3% of PP 145BP
delivery system. The formulation for the test articles is shown below

Test Articles
Material
Poly-Pore

Manufacturing Method: Heat phase A to 45 °C, heat phase B to 45 °C, add phase B to phase A and
homomix, add phase C and phase E, add phase D using a paddle mixer.

Results
The results of the P. acnes scrubs at various time points are listed in the table below.

Statistically equivalent performance is seen in the Poly-Pore formula in comparison to a formulation that
contains 10% free BPO. This data is also shown graphical in Figure 2, below.
Through this result, formulators are now able to provide users with elegant, mild acne treatment products
with the same clinical efficacy as traditional systems. This latitude further broadens the potential
application of BPO into adult acne treatments.
Besides this clinical efficacy, two previous studies have shown that Poly-Pore in both loaded and
unloaded forms can reduce the amount of excess sebum on the skin. Since excess sebum production is
connected to acne, this added benefit can increase the efficacy of a formulation that contains Poly-Pore.
The almost immediate reduction in sebum provides users with a greater sense of satisfaction/gratification
about treatments containing PP 145BP, improving compliance and long-term results.
Figure 2 % Reduction in P. Acnes counts at Day 14.

Source: http://acne-treatment.exposedskincare.com/PolyPore.pdf