Scientific Evidence for The Effectiveness of Hyaluronic Acid Topical Products
The hyaluronic acid topical products may be applied for local treatments such as dermatitis, wound healing and
wrinkles. Mostly, hyaluronic acid is blended with other active ingredients in the topical products. Here is a summary of
Skin - Atopic Dermatitis and Wound Healing
MAS063D is a hydrolipidic hyaluronic acid cream that has been developed for the management of atopic dermatitis.
The putative active ingredients of MAS063D are hyaluronic acid, telmesteine, Vitis vinifera, glycyrrhetinic acid. A
five-week study in 30 adult patients with mild to moderate atopic dermatitis showed that MAS063D offered significant
benefits over placebo. HYALURONIC ACID CREAM.
Skin - Wrinkles and Appearance
A study was conducted to observe the efficacy of topical application of 0.1% hyaluronan (a hyaluronic acid)
formulations of different molecular weights (MW) (50, 130, 300, 800 and 2000 kDa, respectively) in the periocular area
as anti-wrinkle treatment. Measurements of wrinkle depth using mean roughness (Ra) and maximum roughness (Rz)
values revealed significant improvement in the 130 and the 50 kDa HA group after 60 days of treatment compared to
placebo-treated area. HYALURONIC ACID TOPICAL PRODUCTS
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may experience different side effects and benefits of a product. You are encouraged to report adverse side effects to
FDA, its website is www.fda.gov., or report the adverse side effects to the manufacturer, you should be able to find the
contact information on the label.
There are always new information. Please, send me an email (email@example.com) to correct my mistake(s). Reasonable
care has been taken in preparing this document and the information provided herein is believed to be accurate. The
information is not intended to be a substitute for professional medical advice. It is important to seek the advice of a
physician about any medical condition or symptom or the benefits and side effects of a supplement or a drug product.
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Hyaluronic acid Quick View
Hyaluronic Acid is a polysaccharide composed of alternating molecules of N-acetyl glucosamine and D-glucuronic acid. It
can be found within collagen throughout the body. As the most important space filling substance in the human body.
Hyaluronic Acid holds water to keep collagen hydrated and "youthful". Hyaluronic Acid forms a viscous fluid with
exceptional lubricating properties necessary for the vital functions of many parts of the human body including the skin,
heart valves, aqueous/ vitreous humor of the eye and synovial fluid (joint lubricant). The skin contains over 50% of the
bodies Hyaluronic Acid. Considering that skin is over 70% water and renews itself more readily than most other bodily
tissues. Definitely hyaluronic Acid may have benefits on skin's structure and daily maintenance.
||NEW Drug Name
||OLD Drug Name
||Botulinum toxin type A
||Cervical dystonia, Severe primary axillary
||Botulinum toxin type A
||Temporary improvement in the
appearance of moderate to severe
||Botulinum toxin type A
||Cervical dystonia, Temporary
improvement in the appearance to
moderate to severe glabellar lines
||Botulinum toxin type B
Botox Products and Treatment
The following table lists (based on FDA Alert 08/2009) the established name changes and the approved indications for
each product. The marketed trade names and the product formulations have not changed for these products.
Botox Side Effects Consideration (Boxed Warning)
FDA Alert 08/2009 A Boxed Warning has been added to the prescribing information to highlight that botulinum toxin may
spread from the area of injection to produce symptoms consistent with botulism. Symptoms of the side effects, such as
unexpected loss of strength or muscle weakness, hoarseness or trouble talking (dysphonia), trouble saying words clearly
(dysarthria), loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping
eyelids may occur. Swallowing and breathing difficulties can be life-threatening and there have been reports of deaths
related to the effects of spread of botulinum toxin. Children treated for spasticity are at greatest risk for these side effects,
but Botox side effects can also occur in adults treated for spasticity and other conditions. Cases of toxin spread have
occurred at botulinum toxin doses comparable to those used to treat cervical dystonia and at lower doses. No definitive
serious adverse side effects reports of distant spread of toxin effect have been associated with dermatologic use of
Botox/Botox Cosmetic at approved doses. no definitive serious adverse event reports of distant spread of toxin effect
have been associated with Botox for blepharospasm or for strabismus at approved doses. (Is hyaluronic acid an
alternative for Botox?
Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A)
and Myobloc (Botulinum toxin Type B) 2/8/2008
FDA has received reports of systemic adverse side effects including respiratory compromise and death following the use
of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions (side effects) reported
are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected.
The most serious cases of side effects had outcomes that included hospitalization and death, and occurred mostly in
children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity
(severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S.
These serious systemic adverse side effects occurred following treatment of a variety of conditions using a wide range of
botulinum toxin doses. FDA is currently reviewing safety data from clinical studies submitted by the manufacturers of
Botox, Botox Cosmetic and Myobloc, as well as post-marketing adverse side effects reports and the medical literature.
Botox (botulinum toxin type A) is approved for treatment of conditions such as blepharospasm (spasm of the eyelids),
cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox
Cosmetic, also botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe
facial frown lines.
Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical dystonia; the safety and
effectiveness of Myobloc for cervical dystonia in children have not been established.
FDA is aware of the body of literature describing the use of botulinum toxins to treat limb spasticity in children and
adults. The safety, efficacy and dosage of botulinum toxins have not been established for the treatment of limb spasticity
of cerebral palsy or for use in any condition in children less than 12 years of age.
The current prescribing information (labeling) for Botox, Botox Cosmetic and Myobloc describes adverse side effects
occurring in regions near the site of injection for each product’s approved uses, such as dysphagia (difficulty swallowing)
after injections to treat cervical dystonia, or ptosis (drooping eye lids) after injections for glabellar frown lines or for
strabismus and blepharospasm.
The Warnings sections of the labeling for both botulinum toxin products note that important systemic adverse side
effects, including severe difficulty swallowing and difficulty breathing have occurred in patients with neuromuscular
disorders after local injection of typical doses of botulinum toxin. FDA now has evidence that similar, potentially life-
threatening systemic toxicity from the use of botulinum toxin products can also result after local injection in patients with
other underlying conditions such as those with cerebral palsy associated limb spasticity. Systemic toxicity has been
reported in children, several of whom required feeding tubes and/or ventilation (breathing) support.
Botox is a drug made from a toxin produced by the bacterium Clostridium botulinum. It's the same toxin that causes a
life-threatening type of food poisoning called botulism. Doctors use it in small doses to treat health problems, including
temporary removal of facial wrinkles, severe underarm sweating, cervical dystonia - a neurological disorder that causes
and misaligned eyes.