A Double-Blind Randomized Study Comparing The Association of Retinol and LR2412 With Tretinoin 0.025% in Photoaged Skin

Original Contribution
Journal of Cosmetic Dermatology, 14, 40--46
A double-blind randomized study comparing the association of

Retinol and LR2412 with tretinoin 0.025% in photoaged skin
Anne Bouloc, MD, PhD,1 Andre Luiz Vergnanini, MD,2 & Maria Claudia Issa, MD, PhD3
1
Vichy Laboratoires, Asnieres, France
2
Allergisa Pesquisa Dermato-Cosmetica Ltd., Campinas, Brazil
3
Department of Dermatology, Fluminense Federal University, Rio de Janeiro, Brazil
Abstract Introduction Topical tretinoin is considered the gold standard to treat photoaged skin,
but it is associated with side effects and only available upon prescription.
Aim of the study To compare the efficacy, tolerance, and perception of a fixed
proprietary combination (Retinol 0.2%/LR2412 2%) vs. tretinoin 0.025% cream in
women with photoaged skin.
Material/Methods In this randomized, parallel, double-blind, controlled clinical study,
women applied to the entire face for 3 months in the morning a SPF 50 sunscreen
and in the evening either the association of Retinol 0.2%/LR2412 2% or tretinoin
0.025%. Clinical and instrumental parameters were assessed at days 0, 28, 56, and
84. Subject perception of the efficacy, tolerance and cosmeticity of the tested products
were assessed at days 28, 56, and 84.
Results A total of 120 women (60 to Retinol 0.2%/LR2412 2% cream and 60 to
tretinoin 0.025% cream) were included in the study. Both products improved
considerably wrinkles, mottled pigmentation, pores, and global photodamage. No
statistically significant differences were noted between Retinol 0.2%/LR2412 2%
cream and tretinoin 0.025% cream. Adverse effects were mostly graded mild. Overall,
Retinol 0.2%/LR2412 2% cream was better tolerated than tretinoin 0.025% cream.
At all visits, subject perception of the association of Retinol 0.2%/LR2412 2% was
either comparable to or better than tretinoin 0.025% cream.
Conclusion The treatment outcome of Retinol 0.2%/LR2412 2% cream does not differ
from the one of tretinoin 0.025% cream. Clinical results were not statistically
different. Furthermore, Retinol 0.2%/LR2412 2% cream is better tolerated and better
perceived by women used to rejuvenation procedures.
Keywords: LR2412, photoaging, retinol, tetra-hydro-jasmonic acid, tretinoin
Introduction
Correspondence: Anne Bouloc MD, PhD, Vichy Laboratoires, 110 avenue
Henri Barbusse, 92602 Asnieres sur Seine, France. E-mail: anne.bou-
Nowadays, the quest for youth and beauty has become
loc@loreal.com an important issue. Improvement of visible signs of
Funding: Vichy Laboratoires aging such as wrinkles, lack of firmness, dilated skin
Accepted for publication September 26, 2014 pores, and mottled pigmentation has become a concern
impacting the women’s quality of life and representing
This is an open access article under the terms of the Creative Commons
Attribution-NonCommercial-NoDerivs License, which permits use and
an important reason for consulting a dermatologist.1
distribution in any medium, provided the original work is properly cited, Tretinoin has been used in dermatology since the
the use is non-commercial and no modifications or adaptations are made. 1960s, and its potential in the treatment of skin aging
40 © 2015 The Authors Journal of Cosmetic Dermatology Published by Wiley Periodicals, Inc.
14732165, 2015, 1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/jocd.12131 by Rwanda Hinari NPL, Wiley Online Library on [20/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
The association of Retinol and LR2412 . A. Bouloc et al.
has been reported in the 1980s by Kligman et al.2 In addition to LR2412 2% and retinol 0.2%, the
Since then, tretinoin has become the gold standard in proprietary association also contains adenosine and
the treatment of photoaged skin.3,4 Its clinical efficacy HA. To date, skincare products containing retinol,
in the treatment of photoaging has been investigated adenosine, and hyaluronic acid (Retinol HA day and
and proven more than for any other treatment includ- night, Vichy Laboratoires, France) have demonstrated
ing any other retinoid.5,6 their efficacy in optimizing the treatment outcome of
However, its use is also associated with a certain type A botulinum toxin injections.15
number of adverse effects (pruritus, burning sensation, The aim of this current study was to compare the
erythema, and desquamation) currently known as “reti- efficacy, tolerance, and subject perception of a fixed
noid reaction”. These effects are more common with proprietary combination (Retinol 0.2%/LR2412 2%)
tretinoin and tazarotene than with isotretinoin, adapa- vs. tretinoin 0.025% cream in women used to rejuve-
lene, retinol, and retinaldehyde.5 In contrast to the irrit- nation procedures, with at least moderate photoaged
ancy potential of classical retinoid therapies, cosmetic facial skin.
and cosmeceutical antiwrinkle products are generally
well tolerated by the skin and are pleasant to use.7
Materials and methods
While there are only few published reports of direct com-
parative studies, it is generally presumed that such prod-
Settings
ucts do not have clinical efficacy comparable with that
of prescription topical therapies such as tretinoin.7,8 The study was performed at one investigational site in
Products containing retinol have been used in cos- Brazil between April and September 2013 in accordance
metics since 1984. Retinol rationale in the treatment with the Good Clinical Practices and the principles of
of photoaging was proven when Kang et al. showed the Declaration of Helsinki and after approval by an
that application of all-trans-retinol on normal human independent ethics committee. A randomized, parallel,
skin induces epidermal thickening and enhances the double-blind study design was chosen to guarantee the
expression of CRABP II and CRBP mRNAs and pro- quality of the data collected and to reduce limitations.
teins, as does retinoic acid, while only showing mini-
mal signs of erythema and irritation unlike tretinoin.9
Subjects
Moreover, retinol was shown to produce considerably
less transepidermal water loss, irritancy, erythema, and Women aged from 45 to 65 years with a score of II or
scaling than tretinoin and several clinical studies dem- III (moderate to advanced aged skin) on the Glogau
onstrated its relative capacity in monotherapy to aging scale,16 with a Phototype of I to VI on the Fitz-
improve fine wrinkles or aged skin.10–12 patrick scale and who underwent at least one anti-
LR2412 or tetra-hydro-jasmonic acid is a potent aging procedure (i.e., botulinum toxin injection, laser,
derivative of jasmonic acid involved in plant wound skin peeling) within the last 2 years, but not within
repair and tissue regeneration. LR2412 has shown in the last 3 months before the study start and who had
vitro and in vivo its efficacy in counteracting signs of stopped their facial anti-aging products 15 days prior
skin aging.13,14 Indeed, LR2412 enhances in vitro the to the study start were suitable for this study.
deposit of hyaluronic acid (HA) in the basal and supra-
basal layers of the epidermis. LR2412 stimulates the
Treatments
hyalurosome and increases HA Synthases 2 and 3 and
CD44 (HA receptor) expression. Furthermore, LR2412 Women who met all inclusion criteria were randomized
stimulates keratinocytes in the basal layer, and it in a 1:1 manner to either Retinol/LR2412 (Retinol
increases the epidermis thickness. LR2412 also 0.2%/LR2412 2% cream, Liftactivâ Advanced Filler or
strengthens collagen IV, laminin-5, and fibrillin at the Retinol HA Advancedâ, Vichy Laboratoires– France) or
dermal–epidermal junction.14 Clinical investigations on tretinoin 0.025% cream (Vitanol-A cream, Stiefel
the appearance of crow’s feet wrinkles conducted over laboratories, Sao Paulo, Brasil). They were instructed to
3 months of daily application demonstrated that apply the products on the entire face in the evening
LR2412 reduced facial wrinkles.14 LR2412 also after cleansing of their face and prior to bedtime. In
reversed steroid-induced atrophy.14 Moreover, LR2412 addition, all subjects received Sunscreen SPF 50 (pro-
improves the mechanical properties of the skin and it vided by Laboratoires Vichy, France) to be applied on
increases the deposition of fibrillin-rich microfibrils. the face in the morning.
© 2015 The Authors Journal of Cosmetic Dermatology Published by Wiley Periodicals, Inc. 41
Assessments Statistics
Clinical assessments Exploratory data analysis was performed. Time-points

Clinical efficacy evaluations of wrinkles (frontal and were compared through the paired Student t-test using
glabellar area, eyes area, nasolabial fold), pores, and the two-sided hypothesis for Primos data and the ordi-
pigmentation were performed by a dermatologist using nal logistic regression for the efficacy data. Time-points
the photonumeric scales for aged skin developed by were compared through the paired Student t-test for
l’Oreal17 before the first product application on Day independent samples with the two-sided hypothesis for
0 (baseline) and then on Day 28, Day 56, and Primos data and using an ordinal logistic regression
Day 84. The Dermascore18 was used to assess, at all for the efficacy data.
study visits, changes in pores and pigmentation. The number of subjects for the Primos parameters
The Dermascore device is a modified dermatoscope was set at 32 for Retinol/LR2412 and 27 for tretinoin
equipped with appropriate polarizing filters. The color 0.025%. For the efficacy data, 51 and 49 subjects for
aspect alone is observed by removing the specular Retinol/LR2412 and tretinoin 0.025%, respectively,
component with a cross-polarized analyzer, whereas were deemed necessary. The confidence level for the
the pore visibility is strengthened by increasing the comparative analysis was set at 95%. XLSTAT 2013,
proportion of specular reflexion with a parallel polar- STATA 10, and MINITAB 14 were used for the statisti-
ized analyzer. cal analyses.
Three-dimensional measurements Results

Three-dimensional measurements of the periorbital
skin relief (wrinkles, fine lines, and skin texture) were Demographics and baseline data
performed using the Optical 3D Skin Measuring Device
PRIMOS Compact 5.075 (GFMesstechnik GmbH, A total of 177 women were screened and 120 were ran-
Teltow, Germany). This device is based on digital stripe domized to one of the 2 products. One hundred women
projection and allows highly precise and reliable mea- completed the study, as 11 discontinued due to adverse
suring data acquisition.19 events and 9 for other nonrelated personal reasons.
Mean values of roughness, depth, and texture were Demographic and baseline data in both groups were
calculated from parameters measured along 16 lines comparable. All women were aged 45–65 years with a
around a defined point of the area to be evaluated. mean age of 50 in both groups. A total of 66 subjects,
Subjects remained for at least 30 min prior and during 33 in each group, had instrumental measurements per-
instrumental measurements in a room with controlled formed. Fitzpatrick phototypes ranged from type I to
temperature (20 °C 2 °C) and a relative humidity of type V. The majority in both groups had Phototype III.
50% 5%. A decrease of values indicated an improve- All women had a Glogau score of at least II; the majority
ment of the skin relief. in both groups had a score of III, and all had undergone
at least once facial rejuvenation procedure (Table 1).
Subject’s self-assessment questionnaire
Subjects were asked to complete at Day 28, Day 56, Efficacy
and Day 84 a self-perceived efficacy assessment Clinical assessments
comprising efficacy, cosmeticity, and tolerance criteria. After 84 days of treatment with Retinol/LR2412, a sta-
Assessments were to be made as totally agree, agree, tistically significant improvement was observed with
disagree, or totally disagree for the following state- Retinol/LR2412 for glabellar wrinkles (1.9 0.8 vs.
ments; the higher the score, the higher the agree- 2.3 0.8), supralabial wrinkles (1.1 0.9 vs.
ment. 1.5 0.8), nasolabial fold (2.5 0.8 vs. 2.9 0.9),
pores (2.5 1.6 vs. 3.6 1.5), and pigmentation
Safety and local tolerance (1.5 0.9 vs. 2.3 1.2) (all P < 0.05). These differ-
Clinical safety was assessed by the investigator at all ences were sustained from Day 56 onwards for wrinkles
study visits and comprised local tolerance (erythema, and from Day 28 onwards for pores and pigmentation.
dryness, desquamation, burning sensation, and pruri- Improvement of horizontal wrinkles on the forehead
tus) as well as any other adverse event reported spon- (1.9 1.0 vs. 2.1 0.9) and crow’s feet (2.3 1.0
taneously by the subjects. vs. 2.5 1.0) was statistically not significant.
Table 1 Demographic and baseline data Subject’s self-assessment questionnaire

Women gave either similar or better ratings to Retinol/
Retinol/LR2412 Tretinoin 0.025%
LR2412 than to tretinoin 0.025%: it made their skin
n (%) n (%)
softer, smoother, and more elastic, it attenuated the
Age (years) irregular color of the skin, and it reduced pores (all
Mean SD 50 4.04 50 4.45 P ≤ 0.05). Furthermore, it did not leave the skin oily,
Number of Subjects 60 (100%) 60 (100%) sticky, or shinning, and it left the skin comfortable (all
Phototype
I 0 (0%) 1 (0.8%) P ≤ 0.03). In addition, more women felt that Retinol/
II 5 (4.2%) 9 (7.5%) LR2412 caused less burning, heat, or redness sensa-
III 30 (25.0%) 38 (31.7%) tion on the skin and that it did not dry their skin or
IV 25 (20.8%) 10 (8.3%)
caused skin desquamation (all P ≤ 0.01). Results are
V 0 (0%) 2 (1.7%)
VI 0 (0%) 0 (0%) depicted in Figure 3a, b, c.
Total 60 (100%) 60 (100%)
Glogau Score
II (moderate) 21 (35.0%) 19 (31.67%) Safety
III (advanced) 39 (65.0%) 41 (68.33%)
Facial rejuvenation procedures 60 (100%) 60 (100%) 120 women were randomized to one of the two prod-
ucts. One hundred women completed the study, as 11
After 84 days of treatment with tretinoin 0.025%, a discontinued due to adverse events (8 related to the
statistically significant improvement was observed for products and 3 nonrelated) and 9 for personal reasons.
nasolabial fold (2.4 0.9 vs. 2.8 0.7), supralabial Among the 100 subjects that completed the study, 17
wrinkles (1.1 0.8 vs. 1.5 0.9), pores (2.0 1.6 presented adverse events during the study (15 related
vs. 3.2 1.7), and pigmentation (1.6 1.0 vs. to the products and 2 nonrelated).
2.3 1.2) (all P ≤ 0.05). These differences were sus- A total of 23 women reported 23 product-related
tained from Day 56 onwards for nasolabial folds, pores, adverse events during the study. Of these, 8 adverse
and pigmentation. The difference between Day 84 and events in 8 subjects were related to Retinol/LR2412
Day 0 was not statistically significant for glabellar and 15 events in 15 women were related to tretinoin
wrinkles (1.8 0.9 vs. 2.2 0.9), crow’s feet 0.025%. All related adverse events, except one experi-
(2.1 1.0 vs. 2.5 0.9), and horizontal wrinkles on enced with tretinoin 0.025% on the back of one
the forehead (1.6 1.0 vs. 1.9 0.9). woman, were limited to the application areas. They
Overall, visible signs of photoaging improved in both comprised mild or moderate irritation, erythema, dry-
treatment groups. Improvement was the most important ness, fissures, burning, and itching.
for supralabial wrinkles, pores, and pigmentation Regarding Retinol/LR2412, 5 adverse events lead to
(Fig. 1). No statistically significant differences between premature study discontinuation: 2 women reported
both treatment groups were observed, except for glabellar moderate burning on malar and temporal areas; one
wrinkles in favor of the association of Retinol/LR2412. reported moderate burning on the malar and supralabi-
al areas; one reported burning, desquamation, and mod-
Three-dimensional measurements erate erythema on the frontal an malar areas; and one
A significant improvement was observed with Retinol/ reported erythematous edematous pruriginous plaques
LR2412 and with tretinoin for the roughness, depth on the upper eyelids and right malar area. Three other
and texture as early as Day 28. The mean difference at women continued the study until completion: two had a
Day 84 compared to Day 0 was 21.76 6.58 for mild spontaneously resolutive burning sensation with-
roughness, 21.09 6.07 for depth, and 7.18 out any clinical irritation, and one had a mild burning
2.65 for texture with Retinol/LR2412 (all P ≤ 0.03). sensation with mild desquamation on the malar area.
At Day 84, the mean difference from Day 0 was Regarding tretinoin 0.025%, 3 related adverse
19.74 6.88 for roughness, 19.99 7.26 for events lead to premature study discontinuation: one
depth and 5.44 2.36 for texture with tretinoin (all woman had intense dryness, swelling of the upper eye-
P ≤ 0.03). lids, and desquamation; one had burning, dryness, and
The results are depicted on Figure 2. There was no erythema on the malar areas; and one reported burn-
statistically significant difference between the outcome ing sensation and dry skin. Twelve other women con-
of both products regarding periorbital skin relief as tinued the study until completion. They all had
measured with Primos. burning sensation, erythema, and desquamation.
Renol/LR2412 Trenoin 0.025%

Glabellar wrinkles Nasolabial Fold Supralabial wrinkles Pores Pigmentaon
0
-5
-10
-15
*
-20 * *
NS
-25 * *
* **
*
-30
NS ***
-35
NS
-40
**
-45
**
-50 NS
*: p < 0.05 **: p < 0.01 ***: p < 0.001
Figure 1 Clinical Improvement of Visible Signs of Photoaging after 84 Days of Treatment compared to Day 0. *P < 0.05: **P < 0.01:
***P < 0.001.
Renol/LR2412 Trenoin 0.025% the efficacy and tolerability of a 3-month treatment of

Roughness Depth Texture tri-retinol 1.1% gradual release cream vs. tretinoin
0 0.025% cream. They reported similar efficacy with
-2
both products as well as similar side effects. On the
-4
other hand, in our study, Retinol/LR2412 applied daily
-6
* for 84 days did not provide a different treatment out-
-8
* come to that of tretinoin at 0.025%, but less side
-10
-12
NS effects were observed with Retinol/LR2412. Our find-
-14 ings were thus in line with those reported by Ho et al.
-16 and by Kang et al. for retinol containing products.9,20
-18 Subjects’ perception confirmed the good safety profile
-20
** * of Retinol/LR2412: subjects considered that the daily
-22 *
** ** use of Retinol/LR2412 was safer than that of tretinoin
-24
NS
-26
NS 0.025%. These results are not unexpected as a reason
for the good safety profile Retinol/LR2412 may reside
in the anti-inflammatory characteristics of LR241214
*: p < 0.05 **: p < 0.01 ***: p < 0.001
according to the LR2412 ability of inhibiting the syn-
Figure 2 Improvement of Periorbital Skin Relief at Day 84 com- thesis of mediators such as IL8 and PGE2 involved in
pared to Day 0. *P < 0.05: **P < 0.01: ***P < 0.001. inflammation and irritation.
Not surprisingly, subjects preferred Retinol/LR2412
over tretinoin 0.025%. Retinol/LR2412 was developed
Overall, Retinol 0.2%/LR2412 2% cream was better as a cosmetic product, and a high cosmeticity is one of
tolerated than tretinoin 0.025% cream. the main advantages of such products. One may con-
sider that this criterion compared to clinical and
instrumental assessments is not fundamental. How-
Discussion
ever, with the photoaged skin needing regular and
To our knowledge, to date, there is only data from one long-term management, products with a high cosmeti-
published clinical study that compares directly the effi- cal acceptance combined with a good efficacy and
cacy of a retinol containing product to that of product safety profile play an important role in the treatment
containing tretinoin.20 In this study, authors compared compliance and finally in the treatment success.
(a) Eﬃcacy
*
** * ** *
4
3,5
Mean score
2,5
1,5
0,5
0
Skin is soer Skin is more elasc Skin is smoother Irregular skin color Pores are reduced
looks aenuated
*: p < 0.05 **: p < 0.01
(b) Cosmecity
* * ***
*
4
3,5
3
Mean score
2,5
1,5
0,5
0
Does not leave the Does not leave the Does not leave the Leaves the skin
skin oily skin scky skin shiny comfortable
*: p < 0.05 **: p < 0.01 ***: p < 0.001
(c) Tolerance
4,5 ** ** * **
4
3,5
3
Mean score
2,5
1,5
0,5
0
Does not cause a burning Does not cause heat or Does not cause dryness Does not cause
sensaon redness desquamaon
*: p < 0.05 **: p < 0.01
Figure 3 Self-perception by Subjects at Day 84. (a) Efficacy. *P < 0.05: **P < 0.01. (b) Cosmeticity. *P < 0.05: **P < 0.01:
***P < 0.001. (c) Tolerance. *P < 0.05: **P < 0.01.
Although this study was conducted at only one propionate product regimen vs. a prescription 0.02%
investigational site, we consider that the double-blind, tretinoin product regimen. Br J Dermatol 2010; 162:
randomized design chosen to conduct the study and 647–54.
the representative sample size allowed reducing even- 8 Bruce S. Cosmeceuticals for the attenuation of extrinsic
and intrinsic dermal aging. J Drugs Dermatol 2008; 7
tual concerns for limitations for this type of study. We
(2 Suppl): s17–22.
recognize that a longer study and a larger cohort size
9 Kang S, Duell EA, Fisher GJ et al. Application of retinol
would have provided even more robust conclusions. to human skin in vivo induces epidermal hyperplasia
Besides the rigorous double-blind randomized study and cellular retinoid binding proteins characteristic of
design, one of the strengths of the study is the self- retinoic acid but without measurable retinoic acid lev-
assessment questionnaire. The patients are the ultimate els or irritation. J Invest Dermatol 1995; 105:
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A antagonizes decreased cell growth and elevated colla-
gen-degrading matrix metalloproteinases and stimulates
Conclusion collagen accumulation in naturally aged human skin.
J Invest Dermatol 2000; 114: 480–6.
In conclusion, the treatment outcome of the association
11 Fluhr JW, Vienne MP, Lauze C et al. Tolerance profile of
of Retinol 0.2%/LR2412 2% does not differ from the one
retinol, retinaldehyde and retinoic acid under maximized
of the gold standard prescription product tretinoin. Fur- and long-term clinical conditions. Dermatology 1999; 199
thermore, Retinol 0.2%/LR2412 2% cream is better tol- (Suppl 1): 57–60.
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rejuvenation procedures. Its clinical advantages allow photodamage using a novel retinol formulation. J Drugs
Retinol 0.2%/LR2412 2% cream to be an appreciated Dermatol 2013; 12: 533–40.
over-the-counter alternative to topical anti-aging treat- 13 Michelet JF, Olive C, Rieux E et al. The anti-ageing poten-
ments containing tretinoin while providing additional tial of a new jasmonic acid derivative (LR2412): in vitro
benefits in cosmeticity, tolerance, and potential patient evaluation using reconstructed epidermis Episkin. Exp
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14 Tran C, Michelet JF, Simonetti L et al. In vitro and in vivo
studies with tetra-hydro-jasmonic acid (LR2412) reveal
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A Double-Blind Randomized Study Comparing The Association of Retinol and LR2412 With Tretinoin 0.025% in Photoaged Skin

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A Double-Blind Randomized Study Comparing The Association of Retinol and LR2412 With Tretinoin 0.025% in Photoaged Skin

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Original Contribution

Journal of Cosmetic Dermatology, 14, 40--46

A double-blind randomized study comparing the association of

Clinical assessments Exploratory data analysis was performed. Time-points

Three-dimensional measurements Results

Table 1 Demographic and baseline data Subject’s self-assessment questionnaire

Renol/LR2412 Trenoin 0.025%

: p < 0.05 : p < 0.01 : p < 0.001

Renol/LR2412 Trenoin 0.025% the efficacy and tolerability of a 3-month treatment of

Renol/LR2412 Trenoin 0.025%

*: p < 0.05 **: p < 0.01

Renol/LR2412 Trenoin 0.025%

: p < 0.05 : p < 0.01 : p < 0.001

*: p < 0.05 **: p < 0.01

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