INDICATIONS

Palmoplantar keratodermas (PPKs)

Hereditary disorders of keratinization. Characterized by epidermal thickening of palms & soles. Areas of pressure or trauma, soles are often more affected than hands. Hands may show calluses, manual labor may exacerbate palmar hyperkeratosis.
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Keratoderma of the feet

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Keratoderma of the hand

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THERAPIES
Palmoplantar Keratodermas
Keratolytics are the mainstay of therapy. Corticosteroid therapy Use of topical & oral retinoids has also been described.

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MOMATE-S PRODUCT CHARACTERISTICS

Composition
Mometasone furoate
Salicylic acid Ointment base
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0.1%
5% q.s.

MOMETASONE FUROATE DRUG PROFILE

Pharmacological properties
Potent topical steroid. Has high lipophilicity & displays greater affinity for glucocorticoid receptors. Little potential to suppress HPA-axis. Potent & a safe product. Little topically applied mometasone reaches systemic circulation.
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MOMETASONE FUROATE DRUG PROFILE

Pharmacological properties
Has unique structure (9 & 21 chlorine nucleus1 & furoate ester side chain2). Lacks cross reaction.1 No allergenic potential.1 Longer duration of action.2 Lesser topical & systemic side effects.2
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MOMETASONE FUROATE - DRUG PROFILE

Mechanism of action
Anti-inflammatory activity.
Result from decreased formation, release & activity of the mediators of inflammation [kinins, histamine, liposomal (liposome- microscopic spherical particle formed by lipid bilayer enclosing aqueous compartment) enzymes, prostaglandins & leukotrienes].

Antiproliferative actions.
Reduces hyperplastic tissue characteristic of psoriasis & palmoplantar keratodermas.
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MOMETASONE FUROATE DRUG PROFILE

Mechanism of action
Immunosuppressive properties. Decrease response to delayed & immediate hypersensitivity reactions. Inhibition of toxic effect from antigen & antibody complexes. Inhibiting action of lymphokines, target cells & macrophages. Access of sensitized T lymphocytes & macrophages to target cells are also prevented.
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SALICYLIC ACID - DRUG PROFILE

Pharmacological properties
Beta hydroxy acid, has larger molecule size than their alpha hydroxy acids. Larger molecule size keeps beta hydroxy acid on surface of skin, allowing it to more effectively penetrate & exfoliate. This action makes it an ideal exfoliant.
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SALICYLIC ACID - DRUG PROFILE

Pharmacological properties
Larger molecule size produces less irritation than alpha hydroxy acids, making it a welcome alternative for those with sensitive skin.
Addition of salicylic acid to corticosteroid enhances penetration of steroid as well as clinical efficacy.
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SALICYLIC ACID - DRUG PROFILE

Mode of action
Keratolytic agent, removes thick scale & enables other topical therapies to better penetrate skin.

Also known for its antifungal action.

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METHOD OF ADMINISTRATION
Apply thin layer to affected skin areas once or twice daily.
Maximum daily dose is 15 gm applied, should be no more than 30% of body surface.

Treatment duration for longer than 3 weeks has not been evaluated.
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SPECIAL WARNINGS & PRECAUTIONS FOR USE

Momate-S is not for use on face or groin areas, or other intertriginous areas.

Momate-S is not for ophthalmic use.

Care must be taken to avoid contact with eyes, mucosa & open wounds. Momate-S should not be used on ulcers, wounds, or stretch marks. Momate-S is not recommended for use in pustular or guttae psoriasis.
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SPECIAL POPULATIONS
Paediatric use
Safety & efficacy of Momate-S has not been established in children below age of 12 years.

Pregnancy and lactation

Safety of Momate-S in pregnant women has not been established.
Not known whether topical administration could result in sufficient systemic absorption to produce detectable quantities in breast milk, hence not recommended during lactation unless clearly necessary.
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COMPARATIVE EFFICACY
Studies have indicated superiority of combination (mometasone furoate 0.1% + salicylic acid 5%) over mometasone furoate 0.1% alone. After 3 weeks improvements in total disease scores (65 to 75% with combination) compared to 61 to 68% with mometasone alone. Combination was superior to topical salicylic acid 5% alone, improvement in total disease signs scores after 21 days was 75% with the combination & 39% with salicylic acid alone. Combination was more effective than topical fluocinonide 0.05%.
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CONTRAINDICATIONS
Hypersensitivity to mometasone, salicylic acid or any component in this preparation. As with other topical glucocorticoids, contraindicated in patients with bacterial (e.g, pyodermas, syphilis, & tuberculosis), viral (e.g., herpes simplex, varicella, herpes zoster, warts, genital warts, warts), or fungal (dermatophytes and yeasts), & parasitical infections & in patients with perioral dermatitis, rosacea, acne vulgaris, & skin atrophy.
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ADVERSE REACTIONS
Less common (1/100-1/1000) Skin: Striae, secondary infection, papulous rosacea like dermatitis (chronic disease of facial skin), ecchymoses (skin discoloration), folliculitis. Rare (<1/1000)

Endocrine Adrenocortical suppression.

Skin: Hypertrichosis [increased hair growth], sensibilisation [making sensitive] (mometasone), hypopigmentation.
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SUPERIORITY OVER BETAMETHASONE VALERATE

Both offer potent corticosteroid activity. Clinical trial has documented that mometasone was half as potent than betamethasone valerate in suppressing HPA-axis. Clinical trial has documented that mometasone 0.1% was significantly more effective than betamethasone valerate 0.1% in patients with scalp psoriasis.
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SUPERIORITY OVER BETAMETHASONE DIPROPIONATE

Betamethasone dipropionate 0.05% is a moderately potent steroid. Betamethasone dipropionate is associated with a high risk of both topical & systemic adverse effects.

Betamethasone dipropionate is known to induce more skin atropy than mometasone.

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SUPERIORITY OVER BETAMETHASONE DIPROPIONATE

Clinical trial has documented that no clinically significant suppression of HPA-axis was seen after 6 weeks with mometasone, but HPA-axis suppression is documented with betamethasone dipropionate. Clinical trial has documented that mometasone was more effective & offered greater improvement in condition of psoriasis, than betamethasone dipropionate.
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SUPERIORITY OVER HALCINONIDE

Halcinonide 0.1% is a very potent corticosteroid when combined with higher strength 6% of salicylic acid, may result in enhanced keratolysis leading to increased penetration of steroid. Increased potency & enhanced penetration of steroid may lead to increased side effects.

SUPERIORITY OVER HYDROCORTISONE ACETATE

Hydrocortisone acetate 0.5% is a mild steroid unlike Momate-S which offers a potent steroid mometasone.
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SUPERIORITY OVER CLOBETASOL PROPIONATE

Clobetasol propionate is a very potent steroid, hence possibilities of side effects will be more. Clinical evidence states that, clobetasol can induce adrenal suppression, even if applied in small quantities (14 gm/week).

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SUPERIORITY OVER OTHER INGREDIENTS

Urea - Keratolytic agent, helps in enhancing penetration of drug, readily attacked by microorganisms.
Momate-S has ointment base, acts as occlusion & facilitates penetration. Benzoic acid - is used in keratolytic ointments. Documented evidence states, "Atopic individuals have demonstratted reactions to oral & dermal challenge with benzoic aicd or sodium benzoate"
Vogt et al, 1999
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SUPERIORITY OVER OTHER INGREDIENTS

Lactic acid - Keratolytic agent (alpha-hydroxy acid), produces skin irritation because of smaller molecular size. Sodium lactate - Salt of lactic acid, has antimicrobial & humectant properties, used to supplement skins own naturally occurring sodium lactate in order to provide additional moisturising & skin conditions especially under dry conditions. Momate-S has ointment base, acts as occlusion hence prevents water loss compared to cream. Further, salicylic acid is also known for its antimicrobial activity & we give 5% as against 3%.

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COMPETITION
Brand Name Company Composition Packing Price

Betnovate-S cream

GlaxoSmithkline

Betamethasone valerate 0.12%, Salicylic acid 3%, both w/w

20 gm

17.19

Diprovate-MF Croslands Cream Dipsalic Ointment Dipsalic Lotion Lupiderm-S Cream Fulford Fulford Lupin

Betamethasone dipropionate 0.05%,10 gm 37.00 Salicylic acid 3%, Urea 10%, Lactic acid 3%; Sodium lactate 2% Clobetasol propionate 0.05 %, 10gm Salicylic acid 30mg per gm Clobetasol propionate 0.05 %,10 ml Salicylic acid 20 mg per gm Betamethasone (as dipropionate) 0.05% w/w, Salicylic acid 3% w/w
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35.70 30.50 10gm 32.00

COMPETITION
Brand Name Saltopic Ointment Orkid-S Ointment Keralin Ointment Clop-S Cream Lobate-S Ointment Company Systopic Indchemie East India Camlin Nicholas Composition Betamethasone dipropionate 0.64 mg, Salicylic acid 30 mg, per gm Halcinonide 0.1% w/w, Salicylic acid 6.0% w/w Packing 20 gm 10 gm Price 33.50 63.00 31.76 55.00 40.10

Hydrocortisone acetate 0.5%, 15 gm Salicylic acid 6%, Benzoic acid 12%, w/w Clobetasol propionate 0.05%, Salicylic acid 3% Clobetasol propionate 0.05%, Salicylic acid 3%, Urea 10%, Lactic acid 3%, Sodium lactate solution equivalent to lactic acid 2%
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20 gm 15 gm

AVAILABILITY & PACKING

Tubes of 10 gm

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