Cysteamine Cream®

Scientific Product Profile

September 1st, 2017

Cysteamine – New Skin Depigmenting Agent

Cysteamine Cream® is a biological

depigmenting treatment for
hyperpigmentation concerns.

The active ingredient is cysteamine.

Naturally present in human skin cells,
cysteamine regulates melanin synthesis in
the skin.

For the first time, cysteamine is applied in

a topical depigmenting treatment:
Cysteamine Cream®

– Significant depigmenting effectiveness –

– Highly biocompatible and well tolerated –
– Non-cytotoxic, non-mutagenic, non-carcinogenic –
– Superior benefit/risk ratio compared to hydroquinone –
and all other alternatives
WHAT IS CYSTEAMINE?

Cysteamine is the simplest aminothiol

physiologically present in human cells. Product
of natural degradation of the essential amino-
acid L-cysteine, cysteamine is biosynthesized
during the co-enzyme A metabolism cycle (1).

Chemical identity: Cysteamine as constituent of Co-enzyme A.

The natural physiological level

of free cysteamine form at the
natural physiological levels is
well distributed in mammalian
tissues, and a natural
concentration of cysteamine is
highest in mammalian milk.

Natural physiological level of cysteamine in

mammalian cells

Cysteamine has FDA approval for human use. It has a long history of oral use
in human, for the treatment of cystinosis, and has potential for the treatment
of radiation sickness, neurodegenerative diseases and cancer prevention (1).
Another recent registered application of cysteamine is for skin
hyperpigmentation disorders.

Cysteamine Cream® - Scientific Product Profile

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SKIN DEPIGMENTING ACTIVITY

In the 1960s, cysteamine was

demonstrated to have significant
depigmenting activity in animal studies
(2), and later confirmed in in-vitro
studies (3).

Cysteamine was never managed to be

formulated into a topical product due to
its fast oxidation leading to very bad
odor. Scientis Pharma has developed
a new technology to stabilize
cysteamine molecules and significantly
reduce its odor in cream conditions.

For the first time, cysteamine is

introduced as a treatment for skin Evaluation of the efficacy of cysteamine 5% cream
hyperpigmentary disorders (4, 5): in the treatment of epidermal melasma: a
randomized double-blind placebo-controlled trial (4)
Cysteamine Cream®.

Well controlled-clinical studies have consistently confirmed its efficacy in

melasma. Pigment cell researchers have concluded in the higher
depigmenting efficacy of cysteamine compared to hydroquinone (6, 7).

BENEFIT / RISK RATIO

Various depigmenting agents are available and for most of them restricted by
National Health Authorities (FDA and EMA), due to the poor Benefit/Risk ratio.
Hydroquinone and its derivatives are the most popular depigmenting agent
available to treat pigmentary disorders. However, it induces local side effects
(irritation, permanent depigmentation…) and showed mutagenic and
carcinogenic potentials. Other agents have a lower efficacy than
hydroquinone, and likewise can cause side effects (dermatitis, sensitization,
and erythema) and have mild carcinogenic potential.

Cysteamine is shown not to be mutagenic or carcinogenic and interestingly

shows an anti-mutagenic, anti-cancer and anti-melanoma effect demonstrated
in in vitro and in vivo models.

Cysteamine Cream® - Scientific Product Profile

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 Safety profile of five depigmentating agents that have a tyrosinase inhibition activity,
regarding their toxicity, mutagenicity and carcinogenicity

Cysteamine has a very distinctive benefit / risk ratio for the treatment of
hyperpigmentation disorders, superior to the four other depigmenting agents
known to have tyrosinase inhibition activity: Azelaic Acid, Hydroquinone, Kojic
Acid and Retinoic Acid.

Cysteamine has a much better compatibility due to its physiological

biosynthesis in mammalian cells, a significant efficacy profile and a better
safety profile based on toxicity, mutagenicity and carcinogenicity.

Cysteamine is set to replace hydroquinone as the new standard for melasma

hyperpigmentation treatment.

Safety profile of five depigmentating agents that have a tyrosinase inhibition activity,
regarding their toxicity, mutagenicity and carcinogenicity

Cysteamine Cream® - Scientific Product Profile

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REFERENCES
(1) Besouw, Martine; Masereeuw, Rosalinde; van den Heuvel, Lambert;
Levtchenko, Elena (August 2013). "Cysteamine: an old drug with new
potential". Drug Discovery Today. 18 (15-16): 785–792.

(2) Chavin, W.; Schlesinger, W. (August 1966). "Some potent melanin

depigmentary agents in the black goldfish". Die Naturwissenschaften.
53(16): 413–414.

(3) Qiu L, Zhang M, Sturm RA, Gardiner B, Tonks I, Kay G, Parsons PG.
Inhibition of melanin synthesis by cysteamine in human melanoma cells. J
Invest Dermatol. 2000 Jan;114(1):21-7.

(4) Mansouri, P.; Farshi, S.; Hashemi, Z.; Kasraee, B. (July 2015)."Evaluation
of the efficacy of cysteamine 5% cream in the treatment of epidermal
melasma: a randomized double-blind placebo-controlled trial". The British
Journal of Dermatology. 173 (1): 209–217.

(5) Farshi, Susan; Mansouri, Parvin; Kasraee, Behrooz (2017-07-

26)."Efficacy of cysteamine cream in the treatment of epidermal melasma,
evaluating by Dermacatch as a new measurement method: a randomized
double blind placebo controlled study". The Journal of Dermatological
Treatment: 1–8.

(6) Kasraee B. "Deodorized cysteamine* as a depigmenting agent for the

treatment of melasma." Pigment Cell Melanoma Research. 2017;30:e27–
e137

(7) Hsu C. et al. "Cysteamine cream as a new skin depigmenting product."

Journal of the American Academy of Dermatology (2013) 68:4-1 AB189

(8) Goorochurn R. "Cysteamine as the new treatment of human

hyperpigmentation disorders", EADV 2017, September 2017

Cysteamine Cream® - Scientific Product Profile

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HOW TO USE IT
Cysteamine Cream can be applied regardless of the sun intensity, on any skin
phototype, to the face, neck and body, including the normal skin. As
hyperpigmented patches respond more rapidly to Cysteamine Cream than the
normal skin, the skin complexion becomes uniform by continuation of the
treatment.

To achieve effective depigmentation, patients are requested to follow strictly

the daily treatment routine :

1. Do not wash skin before application.

Apply once-a-day as part of your skincare routine, evenings or
morning, to desired skin areas on a rested skin, before washing
it off. If washing necessary (eg. to remove make-up), rest skin for
one hour.

2. Leave for 15 minutes.

Leave Cysteamine Cream on for 15 minutes. After 6 weeks of
daily application and only if there are no signs of skin irritation
(redness, dryness etc) you may gradually leave it on for a little
longer.

3. Wash off.
Wash off thoroughly off with water and soap. Gently pat your
face dry and apply a simple hydrating cream to the treated area

First signs of the depigmenting effect of Cysteamine Cream become visible

after 6 weeks of once-a-day application. Optimal depigmenting results are
achieved after 8 to 12 weeks of once-daily application.

Once the desired depigmenting results are achieved, a twice weekly

applications is required for the maintenance treatment.

Cysteamine Cream® - Scientific Product Profile

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Cysteamine Cream is not just beautifying, it is active.

A burning sensation and mild redness might occur immediately
after application, but it will usually disappear after 30 minutes. This
is a normal reaction and may happen during the first few days of
treatment. No significant side effects, other than light to mild
irritation are reported in only a few cases. In case of sustained
redness, irritation or dry-skin, suspend treatment and carefully
hydrate the area with a basic hydration cream. Patient may
gradually resume treatment once the skin is balanced again — once
again, not washing off your face before, but after the 15 minutes
application.

Cysteamine is the natural product of metabolization of cysteine, a
thiol-based amino acid that is naturally present in abundance in
human cells. Once in contact with the air, the fast oxidation of
cysteamine produces a red cap at the surface of the tube and a
slight natural sulphur-like odor. This is normal and harmless.

No study for use in pregnant and breast-feeding mothers has been
conducted and hence cysteamine must not be used during
pregnancy or when breast-feeding. Avoid using cysteamine if you,
or somebody in your close family, suffer(s) from vitiligo. Do not mix
with other skin treatments. Keep out of reach of children. Store at
room temperature.

Product Registration
Cysteamine Cream® is a Scientis Pharma product, Swiss made, GCP & GMP
compliant, patented and protected. Cysteamine Cream® is registered EAN #
7610136600505 and CPNP # 1264205.
Cysteamine Cream® is available in 50g /1.8oz package at a concentration of
5% cysteamine hydrochloride, free of prescriptions.

Product Composition
Composition: Aqua, Paraf num Liquidum, Cysteamine HCL, Niacinamide,
Butyrospermum Parkii (Shea Butter), Lecithin, Glyceryl Stearate, Isopropyl
Myristate, Cetyl Alcohol, Ascorbyl Palmitate, Ceteareth-20, Sodium Ascorbyl
Phosphate, Octyldodecanol, Phenoxyethanol, Ethylhexylglycerin, Propylheptyl
Caprylate, Ceteareth-12, Cetearyl Alcohol, Cetyl Palmitate, Parfum, Xanthan
Gum, Peg-30 Dipolyhydroxystearate, Tocopherol, Cera Alba, BHT, Tetra
Sodium EDTA, Hexyl Cinnamic Aldehyde, Linalool, Geraniol

Cysteamine Cream® - Scientific Product Profile

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Informations générales
Référence CPNP: 1264205
Référence industrielle:  3000
Version: 1
Date de la première notification: 20/06/2013 09:06:02
Date de la dernière modification:  20/06/2013 09:06:02

Nom du produit Nuances (s'il y a lieu) Langue

CYSTEAMINE CREAM English

Produit spécialement destiné aux enfants de moins de trois ans: Non

Personne responsable:  Louis Tempia SA / Representation fiscale Rapides Savoyards
Adresse de la personne responsable:   BIdaille ZAE 74930 SCIENTRIER France
Téléphone:  +41223421616
Télécopieur +41223420119
Courriel:  jerome.fabre@ltsa.ch
Personne de contact: KASRAEE Behrooz
Adresse de la personne de contact:  23 rue Joseph Girard 1227 CAROUGE Suisse
Téléphone:  +41 78 880 6698
Téléphone supplémentaire 1: 
Téléphone supplémentaire 2: 
Télécopieur 
Courriel:  behroozkasraee@yahoo.com
Produit prêt à être mis sur le marché ou déjà présent sur le marché Oui
Produit importé dans l'Union européenne:  Oui
Pays d'origine: Suisse
État membre de première mise sur le marché:  France

Date de création: 20/06/2013 Statut: Notifié(s) Page: 1 de 4

DG SANCO


Cysteamine Cream® - Scientific Product Profile

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 Cysteamine Cream® - Scientific Product Profile
© Scientis Pharma 2017 8
CONTACT US
Jeff Gouzer
CEO
Scientis Pharma
Campus Biotech, EPFL Innovation Park
Avenue de Secheron 15, CH-1202 Geneva
SWITZERLAND

For all enquiries, contact: we_care@scientispharma.com

COMPANY PROFILE
ScientisPharma is Swiss biotech company, dedicated to skin pigmentation.
We strive at discovering, developing and bringing to patients novel biotech
treatments for skin pigmentation conditions.

Skin pigmentation pathologies are highly frequent in all ethnicities and can
seriously affect the social life of people in all parts of the world. We conduct
research with world-leading scientists and clinicians in the field of skin
pigmentation in order to provide the newest, safest and most effective
treatments to patients with skin colour complexion.

Our lead compound is cysteamine. Natural thiol biosynthesized in human cells

cysteamine regulates melanin synthesis in skin. For the first time, cysteamine
is applied in a topical depigmenting treatment: Cysteamine Cream®.

Cysteamine Cream® - Scientific Product Profile

© Scientis Pharma 2017 8