A 14-Day, Single-Blind, Controlled Study to Assess the Qualitative Improvement in Skin Moisturization and

Desquamation of 15% Lactic Acid Moisturizer with Ceramides (LAMC) Treatment in Healthy Female Subjects
Zoe Diane Draelos1, Steven B  Hall2, Carey Munsick2

1Dermatology Consulting Services, PLLC, High Point, NC, 2Sandoz, Inc., Princeton, NJ

SYNOPSIS
• Traditional moisturizers with emollients (dimethicone, cetyl

alcohol) improve skin appearance by smoothing down dry scaly 

skin to temporarily improve skin appearance.  The dry scaly skin 

ultimately must desquamate for overall healthy skin.

• Topical application of ingredients, such as alpha-hydroxy acids, 

can facilitate the natural skin desquamation process. Lactic Acid 

Moisturizer with Ceramides (LAMC) contains ceramides, 

humectants and lactic acid that work in combination to 

moisturize dry skin and induce desquamation.  

OBJECTIVES
• To investigate if AmLactin® Rapid Relief Restoring Lotion + 

Ceramides (15% LAMC) improves the skin through 

moisturization and desquamation.

• To assess safety by the evaluation of any adverse events 

reported during the study.

METHODS
• This was a randomized, single-center, controlled, evaluator-

blinded, within-subject comparison study of LAMC versus no 

treatment in healthy female subjects where subjects served as 

their own control.  

• Fifty-six female subjects 50+ year of age with dry rough skin on 

the anterior shins (defined as Grade 3-4 on the dermatologist 

evaluation of the skin; Dry Skin Scale) were enrolled and 

treated. 

• All subjects had a template-located target site identified on both 

anterior shins for the purpose of determining the moisturization 

and desquamation potential. 

• The study product was applied to the randomized leg twice daily 

for 14 days.  

• Evaluation of moisturization and desquamation potential were 

assessed clinically using sticky tape corneocyte counts (D-

SQUAME®) as well as dermatologist evaluation (skin dryness, 

skin texture/roughness (tactile), skin texture/roughness (visual), 

desquamation/flakiness, and luminosity/radiance) of the skin at 

Baseline, Day 2 and Day 14.  

• Additionally, photography of the D-SQUAME® discs and 

subjects’ shins were captured Day 1,2 and 14

RESULTS
• LAMC demonstrated clinically and statistically significant 

improvement to no treatment in enhanced moisturization 

and desquamation via D-SQUAMEs at both Day 2 and Day 

14 (-2.51 and -3.07 on a 5-point scale at p<0.0001, 

respectively).  

• Treatment success assessed by the investigator (via the 

Dry Skin Scale) demonstrated statistical significance with 

LAMC, with the majority of p values being <0.0001.  

• LAMC was well tolerated with no reported adverse events 

over the duration of the study. 

CONCLUSIONS

• LAMC provided a statistically significant and clinically 

meaningful improvement in moisturization and 

desquamation as evidenced by D-SQUAME®, Dry Skin 

Scale, and Subject Self-Assessments in the population 

studied. 

• Additionally, the product appeared to be safe and well 

tolerated.

REFERENCES
• Black D, Boyer J Lagarde JM. Int J of Cosmetic Sci, 

2006;28, 35-44

ACKNOWLEDGEMENTS

• We thank Jose Gallo (Sandoz) for his statistical support 

on this study

• We thank Christopher Oh, Sandoz Fellow, for his editorial 

support on this poster

DISCLOSURES
• This Study was funded by Sandoz, Inc., Princeton, NJ

• Hall, Munsick employees of Sandoz Inc.

Amlactin® Rapid Relief is a registered trademark of Sandoz 

Inc.

LAMC Provided Significant Improvement in Moisturization and Desquamation 

by Physician Assessment on the Dry Skin Scale

0

1

2

3

4

5

Dryness Roughness (tactile) Roughness (visual) Flakiness Lack of Luminosity

• Improvement in desquamation 
was associated with significant 
improvements in all 5 subscales 
of the Dry Skin Scale as 
assessed by the physician at 
day 2 and the end of study 
(P<0.0001) 

• LAMC was safe and well 
tolerated
—No adverse events
—No discontinuations

* * * * * * * * * *

Day BL  2  14  BL  2  14     BL  2  14  BL  2  14       BL  2  14  BL  2  14     BL  2  14  BL  2 14         BL  2  14   BL  2  14

LAMC PLB (no product)BL=baseline; PLB=placebo; SD=standard deviation.
*P<0.0001 vs baseline.

Data on file. Sandoz, Inc. 

Dry Skin Scale

M
e

a
n

 (
S

D
)

LAMC Provided Significant Improvement in Moisturization and Desquamation

1.20

3.80

1.75

4.08

4.27

4.25

0.00 1.00 2.00 3.00 4.00 5.00 6.00

L
A

M
C

P
L

B
 

(n
o

 p
ro

d
u

c
t)

Day

1

2

14

1

2

14

D-SQUAME Images Day 14 Shin Images

-3.07*

-0.45

-2.51*

-0.16

Difference 

from BL

BL=baseline; PLB=placebo; SD=standard deviation.

*P<0.0001 vs baseline.

Data on file. Sandoz, Inc. 

Mean (SD)

D-SQUAME Quantification

RESULTS

Day 1 Day 2 Day 14