ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics; Ortho Dermatologics is a division of Bausch Health US, LLC • Presented at The Fall Clinical Dermatology Conference for PAs and NPs • June 3-5, 2022 • Scottsdale, AZ

SYNOPSIS 
 � Vehicle design and optimization of topical formulations are critical to the drug-
development process, as product vehicle and active/inactive ingredients can 
contribute to drug tolerability/efficacy and patient preference/adherence1,2

 � Retinoids are a mainstay of acne treatment, though topical retinoids—such as 
tretinoin—can be associated with significant cutaneous irritation and drying, which 
can lead to poor adherence3,4

 � To mitigate these issues, tretinoin 0.05% lotion (Altreno®) was formulated using a 
polymeric honeycomb matrix, which allows for efficient and uniform delivery of 
micronized tretinoin and moisturizing/hydrating ingredients5,6 (Figure 1)

 � Branded topical acne therapies, however, are often substituted at the pharmacy for 
a generic version, without accounting for the physiochemical differences between 
formulations and the potential impact of this product substitution

FIGURE 1.  Polymeric Emulsion Technology for Tretinoin 0.05% Lotion

Polymeric matrix traps
micronized tretinoin

particles

Micronized tretinoin [Kircik et al. 2019]6. Cryo scanning electron microscopy imaging of the polymeric matrix 
(×1000). Micronized tretinoin particles are predominantly <10 microns in diameter.

OBJECTIVE
 � To compare the tolerability and participant preference of two tretinoin formulations: 
a branded 0.05% lotion (Altreno) and a frequently dispensed 0.05% generic cream 
(Taro)

METHODS
 � In this single-center, double-blinded, split-face study, females with acne aged ≥18 
years were randomized to apply tretinoin lotion or generic cream once daily to the 
right or left cheek for 2 weeks

• First application occurred at the research site under the supervision of a research 
coordinator

 � Assessments were conducted immediately after first use and after two weeks of 
split-face drug application

 � The investigator assessed erythema, scaling, skin dryness, softness, smoothness, 
radiance, and brightness on a 5-point scale (0=none, 1=minimal, 2=mild, 
3=moderate, 4=severe)

 � Participants completed a 16-item facial marketing questionnaire assessing their 
impressions of the products and their skin on a 9-point scale (1=agree completely, 
9=disagree completely) for each side of their face

Participant Assessments 
 � After 2 weeks of use, average impression rating scores on each of the  
16 questionnaire items were better (lower) for lotion versus cream  
(P<0.05 on 15 of 16 items; Figures 3 and 4)

• Similar results were observed immediately after one use (P<0.05 on  
10 of 16 items; data not shown)

 � More than 70% of participants agreed (rating score 1–3) that the tretinoin lotion was 
gentle, comfortable/soothing, spreadable, absorbent, not sticky, and left a minimal 
white residue versus <40% for generic cream (Figure 3)

 � Agreement scores on skin sensation (feels soft, smooth, comforted/soothed/calm, 
not dry and looks smoother, less dull, less flaky) were similarly higher for lotion 
versus cream (>60% vs ≤40%; Figure 4)

 � Overall, approximately 70% of participants preferred to take tretinoin lotion home 
over cream both after first use and 2 weeks of use (Figure 5)

FIGURE 3.  Self-Assessments of Produc t Properties at Week 2 (N=25)

Feels gentle

Feels comfortable/soothing

Relieves tightening sensation

Spreads well

Absorbs well

Is not sticky

Leaves minimal white residue

Has a neutral smell

Overall satisfaction with product

1 2 3 4 5 6 7 8 9

Questionnaire Scale

2.52 *** 5.12

2.64 ** 4.72

3.16 ** 5.60

1.64 *** 7.32

2.12 *** 6.40

3.52 * 6.08

1.92 *** 7.28

2.48 4.16

3.08 *** 5.72

84

80

64

92

88

72

92

84

68

Lotion

32

36

24

8

20

28

12

52

32

Generic
% Agreea

More Agreement More DisagreementTretinoin Lotion
Generic Cream

*P<0.05, **P<0.01, ***P<0.001 vs generic cream. 
Questions rated on a scale of 1=agree completely to 9=disagree completely. 
aDefined as a rating of 1, 2, or 3 on the questionnaire scale.

FIGURE 4.  Self-Assessments of Skin Properties at Week 2 (N=25)

Feels soft

Feels smooth

Feels comforted/soothed/calmed

Does not feel dry

Looks smoother

Looks less dull

Looks less �aky

1 2 3 4 5 6 7 8 9

Questionnaire Scale

2.64 ** 5.04

2.60 ** 4.84

3.28 * 5.52

3.40 ** 5.80

3.20 ** 5.60

3.16 ** 5.52

3.60 ** 6.48

80

80

72

68

76

72

64

Lotion

32

40

24

28

28

28

20

Generic
% Agreea

More Agreement More DisagreementTretinoin Lotion
Generic Cream

*P<0.05, **P≤0.01, ***P<0.001 vs generic cream. 
Questions rated on a scale of 1=agree completely to 9=disagree completely. 
aDefined as a rating of 1, 2, or 3 on the questionnaire scale.

Vehicle Formulation Impacts Tolerability and Patient Preference: Comparison of Tretinoin Branded Lotion and Generic Cream

Zoe D Draelos, MD1; Amber Blair, PA-C2; Emil A Tanghetti, MD3
1Dermatology Consulting Services, PLLC, High Point, NC; 2Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; 3Center for Dermatology and Laser Surgery, Sacramento, CA

RESULTS

Participants
 � Twenty-five female participants with a mean age of 40.6 years (range: 19–69 years) 
enrolled in and completed the study 

 � All participants had a Fitzpatrick skin type of 1 or 2 and self-identified as White

 � Almost half of participants had combination skin type (48%), followed by dry (32%), 
normal (12%), and oily (8%)

Investigator Assessments
 � After first use, investigator assessments were not significantly different between the 
lotion- and cream-treated sides of the face, and there was no/minimal erythema, 
scaling, or dryness with either treatment  
(Figure 2; open bars)

 � At week 2, the cream-treated side of the face had significantly more erythema 
(144%), scaling (144%), and dryness (122%) versus the lotion-treated side (P<0.01 each; 
Figure 2; filled bars)

 � The lotion-treated side also demonstrated significantly enhanced softness, 
smoothness, radiance, and brightness (~40% difference, P<0.01, each) versus cream 
at week 2 (Figure 2; filled bars)

FIGURE 2.  Investigator Assessments of Irritation and  
Skin Appearance (N=25)

0.5

1

1.5

3.5

0

2

2.5

3

Erythema

M
e
a
n
 V

a
lu

e
s

4
Generic Cream: First Use
Tretinoin Lotion: First Use
Generic Cream: Week 2
Tretinoin Lotion: Week 2

Scaling Dryness Lack of
Softness

Lack of
Smoothness

Lack of
Radiance

Lack of
Brightness

minimal

none

mild

moderate

severe

M
o

re
 F

av
o

ra
b

le

**P<0.01 vs generic cream at week 2.

FIGURE 5.  Self-Assessment of Produc t Preference

68%

32%

72%

28%

Overall, which product would you like to take home?

After �rst use After 2 weeks

Tretinoin Lotion

Generic Cream

CONCLUSIONS
 � In this split-face study, tretinoin 0.05% lotion led to significantly 
less investigator-assessed erythema, scaling, and dryness 
versus generic cream after 2 weeks of once-daily use, 
accompanied by a significant improvement in skin appearance 
(softness, smoothness, radiance, and brightness) 

 � Participants also significantly preferred properties of the lotion 
formulation (eg, gentle, spreadable, absorbs well) and skin 
sensation (eg, soft, soothed, not dry, less dull) with lotion 
versus cream 

 � These results demonstrate the importance of a well-designed 
topical formulation—such as tretinoin 0.05% lotion—on both 
improved tolerability and patient preference, underscoring the 
potential negative impact of generic switching at the pharmacy 

• Given the established impact of tolerability and patient 
preference on drug adherence and treatment success,2,7 this 
further underscores the potential negative effect of generic 
switching at the pharmacy

REFERENCES
1. Piacquadio D, and Kligman A. J Am Acad Dermatol. 1998;39(2 Pt 3): S67-73.
2. Eastman WJ, et al. Cutis. 2014;94(1):46-53.
3. Zaenglein AL, et al. J Am Acad Dermatol. 2016;74(5):945-73.e33. 
4. Sevimli Dikicier B. J Int Med Res. 2019;47(7):2987-2992.
5. Tyring SK, et al. J Drugs Dermatol. 2018;17(10):1084-1091.
6. Kircik LH, Draelos ZD, and Berson DS. J Drugs Dermatol. 2019;18(4):s148-154.
7. Dreno B, et al. Int J Dermatol. 2010;49(4):448-56.

AUTHOR DISCLOSURES
Zoe D Draelos received funding from Ortho Dermatologics to conduct the research presented in this poster. 
Amber Blair is Director at Large for the SDPA Board of Directors. Emil A Tanghetti has served as speaker for 
Novartis, Ortho Dermatologics, Sun Pharma, Lilly, Galderma, AbbVie, and Dermira; served as a consultant/
clinical studies for Hologic, Ortho Dermatologics, and Galderma; and is a stockholder for Accure.