Chromophore mapping of hemoglobin for the assessment of axillary

Two well-controlled, randomized and blinded paired comparison clinical studies
were conducted to evaluate axillary irritation and AP efficacy of a Rx AP containing
6.25% Aluminum Chloride versus an OTC anhydrous, Aluminum Trichlorohydrex
GLY AP. The study was conducted for 7-days in healthy females (n=19), with
treatments applied 1X/day in the evening. The panelists were evaluated for
irritation at each visit. If a panelist had an irritation score of 2 or above (Scale:
0=None to 3=Extreme), product application was discontinued for subject safety
and the highest irritation and image scores for that panelist were carried forward for
the analysis. Study measurements: Daily high resolution image capture for
subsequent non-contact SIAscopy evaluation, AP efficacy (Post-trt 6), daily expert
irritation scoring, and daily subject self-reported symptoms. The data were assessed
using mixed models or the marginal homogeneity test.
METHODS
Evaluate the utility of non-contact SIAscopy for the assessment of axillary irritation
via chromophore mapping of hemoglobin with comparison to expert clinical and
subject perceived irritation in axillary skin treated with a mild prescription strength
wetness protection OTC AP and an irritating prescription AP.
OBJECTIVE
Prescription (Rx) antiperspirant (AP) products are widely known to induce irritation
(erythema, stinging, burning) due to the highly acidic nature of the AP active in
vehicles that are not optimized to buffer the skin reactions. This axillary skin
irritation limits patient compliance, thus impeding product efficacy. Previously, we
shared data from two well-controlled clinical studies that established the
prescription strength AP efficacy for an OTC AP compared to a Rx AP1. This
prescription strength wetness protection OTC AP was formulated to be gentle to
the skin by delivering skin-soothing benefits via petrolatum and dimethicone. In
these clinical studies we demonstrate the utility of non-contact SIAScopy
(Spectrophotometric Intracutaneous Analysis, NCS), an image analysis method that
maps skin chromophores (hemoglobin, eumelanin, dermal collagen)2, 3, 4, to examine
the regional distribution and concentration of hemoglobin in axillary skin treated
with a mild OTC AP and an irritating prescription AP.
INTRODUCTION
Original Image
0
0.5
1
1.5
2
2.5
3
3.5
4
0
1
2
3
4
5
6
7
Visit 3
Visit 4
Visit 5
A (Female OTC Anhydrous "Soft Solid")
Visit 2
Visit 6
Visit 7
C (Rx AlCl3 AP)
p=0.0011
p<0.0001
Visit 1
Visit 3
Visit 4
p=0.0138
Visit 6
C (Rx AlCl3 AP)
Visit 5
A (Female OTC Anhydrous "Soft Solid")
Visit 2
p=0.0148
p=0.0114
p=0.0104
Visit 7
p=0.0146
Subject Self Perceived Irritation Score by Visit
Visit 1
p=0.0337
p=0.0001
p=0.0003
Image Analysis- Change from Baseline Hemoglobin Values
NCS Hemoglobin Map
Anhydrous “Soft Solid” OTC AP
Visit 1
Visit 3
Visit 4
Visit 5
A (Female OTC Anhydrous "Soft Solid")
Visit 2
p=0.0124
p=0.0018
p=0.0003
Visit 7
p=0.0004
C (Rx AlCl3 AP)
Visit 6
p=0.0007
0
10
20
30
40
50
60
70
80
Visit 1
Visit 3
Visit 4
p=0.0038
Visit 5
p=0.0024
Visit 7
C (Rx AlCl3 AP)
Visit 6
p=0.0079
4.
3.
2.
1.
Kimball A, Matts, PJ. Characterizing Hyper-pigmented Facial
Lesions Using Clinical Evaluation and a New ChromophoreMapping Technique. American Academy of Dermatology 64th
Annual Meeting, 2006.
Matts PJ, Carey J, Cotton SD. Chromophore mapping: a new
technique to characterized ageing human skin, invivo, American
Academy of Dermatology 63rd Annual Conference, 2005.
Matts, PJ, Fink, B, ,Grammer, K, Burquest, M. Color homogeneity
and visual perception of age, health, and attractiveness of female
facial skin. J Am Acad Dermatol 2007; 57: 977-84.
Thomas M, Kelly Smalls LR, Leazer TM, Finn E, Elstun LT,
Hartwig P, Swaile D, Capretta A. Alternative Topical Treatment to
an Aluminum Chloride Antiperspirant that Provides Prescription
Strength Efficacy with Significantly Less Irritation. American
Academy of Dermatology 65th Annual Meeting, 2007.
References
Acknowledgements:
Image Analysis by Michael Marmor & Kukizo Miyamoto.
the image analysis
method works well in shaved
underarm skin. The method has not
been optimized for unshaved skin. In
clinical
trials,
expert
irritation
assessment is always recommended in
conjunction with image analysis
methods.
¾Currently,
Solid” OTC AP may increase subject
compliance, leading to a more
consistent treatment regimen as
compared to the more irritating Rx
Aluminum Chloride AP.
¾Additionally, the milder “Soft
these data demonstrate
that
non-contact
chromophore
mapping via SIAscopy is an effective
tool for the assessment of axillary
irritation and is consistent with expert
clinical irritation assessments, and
subject self-perceived data.
¾Overall,
CONCLUSIONS
This work was funded by P&G Beauty.
A (Female OTC Anhydrous "Soft Solid")
Visit 2
p=0.0007
p=0.0038
Subject Self-Perceived Irritation Unfavorable Comments
0
0.2
0.4
0.6
0.8
1
1.2
1.4
Expert Visual Irritation Assessment by Visit
Original Image
NCS Hemoglobin Map
Rx Aluminum Chloride AP
Non-contact chromophore mapping of hemoglobin indicated that there was significantly (p<0.05) more irritation for the
Rx AP as compared to the OTC AP (Visits 3-7). Additionally, the hemoglobin data were consistent with significant
findings (p<0.05) for expert clinical visual irritation scores (Visits 3-7) and subject self-assessments (p<0.05, Visits 3-7).
Subject perception data indicated that the irritation from the Rx AP most often felt like stinging and burning. For subject
safety, treatment was discontinued at level 2 irritation (Scale:0-3): n=7 on Rx AP and n=0 on Anhydrous OTC AP.
RESULTS
P&G Beauty, Cincinnati, Ohio USA
Lola Kelly Smalls, PhD, MBA, Laurie Elstun, MS, Amy Capretta, BS, Paula Hartwig, BS, Michael Thomas, MBA, David Swaile, PhD,
Comparison of OTC and Prescription Antiperspirants
Chromophore Mapping of Hemoglobin for the Assessment of Axillary Irritation:
CONCLUSIONS
Female Underarms
P1000
Mean Change from Baseline Hemoglobin Value
(higher= more irritation)
Mean Subject Perceived Irritation Score
(higher= more irritation, Scale- 0-10)
Mean Expert Visual Irritation Score
(higher= more irritation, Scale- 0-3)
% of Subjects Unfavorable Irritation Comments
(higher= more unfavorable)