Schedule H

Topical (Cutaneous, Scalp)

Cream:

• Clobetasol propionate 0.05% w/w (5 g, 10 g, 15 g, 20 g, 30 g tubes)

Ointment:

• Clobetasol propionate 0.05% w/w (5 g, 10 g, 15 g, 20 g, 30 g tubes)

Gel:

• Clobetasol propionate 0.05% w/w (15 g, 20 g tubes)

Lotion:

• Clobetasol propionate 0.05% w/v (25 mL, 50 mL, 100 mL bottles)

Scalp Application/Solution:

• Clobetasol propionate 0.05% w/v (25 mL, 50 mL bottles)

Shampoo:

• Clobetasol propionate 0.05% w/v (50 mL, 100 mL bottles)

Foam:

• Clobetasol propionate 0.05% (limited availability)

Fixed-Dose Combinations (commonly available):

• Clobetasol + Neomycin + Miconazole

• Clobetasol + Gentamicin + Miconazole

• Clobetasol + Salicylic acid (for scalp psoriasis)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

⚠️ CRITICAL: Clobetasol propionate is a SUPER-POTENT (Class I) topical corticosteroid. Reserve for steroid-responsive dermatoses not responding to less potent agents. Limit duration and body surface area treated.

1. Psoriasis (Plaque-type, Palmoplantar, Scalp)

Parameter Dosing Details

Starting dose Apply thin layer to affected area twice daily

Titration Reduce to once daily as inflammation improves; then alternate days

Usual maintenance dose Once daily or alternate day application

Maximum dose Do not exceed 50 g/week; limit continuous use to 2 weeks per course

Key Clinical Notes:

• Scalp psoriasis: Use lotion, solution, or shampoo formulation

• Palmoplantar psoriasis may require occlusion for enhanced penetration

• Avoid face and intertriginous areas

• Reassess if no improvement after 2 weeks

1. Severe Eczema / Atopic Dermatitis (Acute Flares, Lichenified Areas)

Parameter Dosing Details

Starting dose Apply thin layer to affected area twice daily

Titration Reduce frequency once acute inflammation controlled

Usual maintenance dose Once daily; transition to lower potency steroid for maintenance

Maximum dose 50 g/week; maximum 2 weeks continuous use

Key Clinical Notes:

• Use only for acute flares or lichenified/resistant areas

• Step down to mid-potency or low-potency steroids after control achieved

• Avoid in children unless under dermatologist supervision

1. Contact Dermatitis (Severe/Allergic)

Parameter Dosing Details

Starting dose Apply thin layer twice daily

Titration Reduce to once daily as inflammation resolves

Usual maintenance dose Once daily for short duration

Maximum dose 50 g/week; 2 weeks maximum

1. Lichen Planus (Cutaneous)

Parameter Dosing Details

Starting dose Apply thin layer to lesions twice daily

Titration Reduce frequency as lesions flatten

Usual maintenance dose Once daily

Maximum dose 50 g/week; 2–4 weeks per course

1. Discoid Lupus Erythematosus (DLE)

Parameter Dosing Details

Starting dose Apply thin layer to affected areas twice daily

Titration Reduce to once daily as lesions improve

Usual maintenance dose Once daily or alternate days

Maximum dose 50 g/week; short courses with reassessment

Key Clinical Notes:

• Often requires prolonged intermittent therapy

• Monitor for skin atrophy, especially facial lesions

• Sun protection essential

1. Scalp Psoriasis / Severe Seborrhoeic Dermatitis (Scalp)

Scalp Lotion/Solution:

Parameter Dosing Details

Starting dose Apply to affected scalp areas once or twice daily

Titration Reduce to once daily as improvement occurs

Usual maintenance dose Once daily or alternate days

Maximum dose Limit use to 4 weeks per course

Shampoo:

Parameter Dosing Details

Starting dose Apply to wet scalp, lather, leave on for 15 minutes, rinse; use once daily

Titration Reduce to alternate days after initial control

Usual maintenance dose 2–3 times weekly

Maximum dose Daily use for maximum 4 weeks

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Severe eczema/atopic dermatitis, lichenified dermatoses — only when lower-potency steroids have failed

⚠️ NOT recommended below 1 year of age

⚠️ Clobetasol is generally NOT first-line in paediatrics due to high potency and systemic absorption risk

1–6 years Apply very thin layer to affected area ONCE daily Maximum 5 days continuous; strict specialist supervision Smallest area possible; avoid >10% BSA

6–12 years Apply thin layer once daily Maximum 7 days continuous Limit to localised areas

≥12 years Adult dosing with caution Maximum 2 weeks As per adult limits

Key Clinical Notes:

• Use ONLY under dermatologist/paediatrician supervision

• Preferred alternatives: Hydrocortisone (mild), mometasone or fluticasone (moderate) are safer first-line options

• Avoid occlusive dressings in children

• Avoid face, flexures, nappy/diaper area

• Higher surface area-to-weight ratio in children increases systemic absorption risk

Secondary Indications — Paediatric (Off-label)

Not recommended — no established off-label paediatric indications. Any use beyond licensed indications requires specialist dermatology/paediatric supervision.

Clear Statement: ABSOLUTELY NOT recommended below 1 year of age. Use in children 1–12 years ONLY under specialist supervision when lower-potency steroids have failed. Limit duration to shortest possible.

Safety Monitoring in Children:

• Monitor for signs of HPA axis suppression (growth retardation, Cushingoid features)

• Assess treated body surface area at each visit

• Document duration of use

• Watch for local adverse effects (atrophy, striae)

No dose adjustment required — topical application with minimal systemic absorption under normal use conditions.

• Known hypersensitivity to clobetasol propionate or any formulation component

• Untreated bacterial skin infections (impetigo, cellulitis, erysipelas)

• Untreated fungal skin infections (tinea corporis, tinea cruris, candidiasis)

• Untreated viral skin infections (herpes simplex, herpes zoster, varicella, molluscum contagiosum)

• Acne vulgaris

• Rosacea

• Perioral dermatitis

• Primary cutaneous viral infections (including warts)

• Children below 1 year of age

• Ophthalmic use (not for eyes)

• Face application: Avoid unless specifically indicated and supervised — high risk of atrophy, telangiectasia, perioral dermatitis

• Intertriginous areas (axillae, groin, inframammary folds): Increased absorption; use with extreme caution

• Genital area: Specialist supervision required; very thin skin with high absorption

• Prolonged use (>2 weeks continuous): Risk of local atrophy, striae, systemic absorption

• Large body surface area application: Increased systemic absorption risk; avoid >10–20% BSA

• Occlusive dressings: Significantly increase absorption; use only when specifically indicated

• Broken or ulcerated skin: Enhanced systemic absorption

• Children and elderly: Thinner skin increases absorption risk

• Diabetes mellitus: May worsen glycaemic control with extensive use

• History of steroid-induced adverse effects: Atrophy, striae, purpura

• Abrupt discontinuation in chronic use: Risk of rebound flare; taper frequency gradually

Parameter Details

Risk Category Limited human data; topical corticosteroids generally considered low risk when used appropriately. Animal studies show potential fetal harm at high systemic doses.

Preferred alternatives Lower-potency topical steroids (hydrocortisone, mometasone) preferred during pregnancy

When may be used For severe, localised dermatoses not responding to lower-potency agents; use smallest amount for shortest duration; avoid large areas and occlusion

Monitoring Avoid first trimester if possible; monitor fetal growth if prolonged/extensive use; limit application to <50 g/week

Parameter Details

Compatibility Compatible with breastfeeding with precautions

Preferred alternatives Lower-potency steroids (hydrocortisone) if suitable

Drug levels in milk Low — minimal systemic absorption from appropriate topical use

Precautions Do NOT apply to breast or nipple area. If applied elsewhere, ensure infant does not contact treated skin. Apply after breastfeeding.

Infant monitoring No specific monitoring required if used appropriately

Parameter Recommendation

Starting dose Same as adult; apply sparingly

Titration Use minimum effective duration and frequency

Special risks Increased susceptibility to skin atrophy, purpura, telangiectasia, and skin thinning due to age-related skin changes. Higher risk of systemic absorption. Increased bruising tendency.

Monitoring Careful assessment of skin integrity before and during treatment; limit duration

• No significant systemic drug interactions via topical route when used appropriately

• Concurrent use of other topical corticosteroids on same area: Avoid — additive local adverse effects, increased systemic absorption

• High-dose systemic corticosteroids + extensive topical clobetasol: Additive HPA axis suppression risk — avoid or monitor

Interacting Drug/Agent Effect Management

Topical retinoids (tretinoin, adapalene) Increased skin irritation when used on same area Separate application times or use on alternate days

Topical salicylic acid May increase corticosteroid penetration; also additive irritation Use with caution; separate application if possible

Topical immunomodulators (tacrolimus, pimecrolimus) Generally not used simultaneously on same area Use sequentially rather than concurrently

Phototherapy (PUVA, NB-UVB) Corticosteroids may reduce efficacy of phototherapy; also combined skin irritation Discuss with dermatologist; may need to hold steroid before phototherapy

Local (Application Site):

• Burning, stinging, itching (especially initial applications)

• Dryness

• Folliculitis

• Acneiform eruptions

• Pruritus

• Skin irritation

With Prolonged Use:

• Skin atrophy (thinning)

• Striae (stretch marks) — irreversible

• Telangiectasia

• Purpura, ecchymosis

• Hypopigmentation (especially in darker skin)

• Hypertrichosis

Adverse Effect Clinical Notes

HPA Axis Suppression With extensive use, large surface area, occlusion, or prolonged therapy. May present as adrenal insufficiency on withdrawal. More common in children.

Iatrogenic Cushing's Syndrome Rare; with prolonged extensive use. Presents with moon face, central obesity, hyperglycaemia.

Steroid-Induced Skin Atrophy May be irreversible; cigarette-paper thin skin, visible vessels.

Steroid Rosacea / Perioral Dermatitis From inappropriate facial use; difficult to treat after established.

Secondary Skin Infection Masking of infection signs; may worsen underlying tinea (tinea incognito), scabies, or bacterial infection.

Allergic Contact Dermatitis To vehicle components or steroid itself; may mimic treatment failure.

Rebound Phenomenon / Withdrawal Flare On abrupt discontinuation after prolonged use; may be severe.

Glaucoma / Cataracts With periocular application — avoid near eyes.

Growth Retardation (children) With extensive/prolonged use; HPA suppression affects growth.

During treatment Monitor for local adverse effects (atrophy, striae, telangiectasia, hypopigmentation); assess treatment response at 2 weeks; check for signs of secondary infection

If extensive/prolonged use Morning cortisol level if HPA suppression suspected; glucose monitoring in diabetics; growth monitoring in children

Long-term Avoid continuous use >2 weeks without reassessment; document cumulative use; assess need for step-down to lower-potency steroid

Plain Clobetasol Propionate:

• Tenovate® (GSK) — Cream, Ointment, Lotion

• Lobate® (Abbott/Torrent) — Cream, Ointment

• Clobet® (Glenmark) — Cream, Ointment

• Topinate® (Systopic) — Cream, Ointment

• Clop® (Cipla) — Cream, Ointment

• Cloderm® (Hegde & Hegde)

• Dermovate® (GSK) — Cream, Ointment, Scalp Application

Scalp Formulations:

• Sorvate® (Dr. Reddy's) — Scalp Lotion

• Tenovate-S® (GSK) — Scalp Application

• Clobex® Shampoo (limited availability)

Fixed-Dose Combinations (commonly available):

• Tenovate-GN® (Clobetasol + Neomycin + Miconazole)

• Lobate-GM® (Clobetasol + Gentamicin + Miconazole)

• Numerous other combinations with antifungals/antibacterials

Note: Clobetasol propionate is NOT listed in NLEM 2022. Not under NPPA price control. Prices vary significantly between brands and generics.

1. Fingertip Unit (FTU) for patient counselling — One FTU (from fingertip to first crease, ~0.5 g) covers approximately one hand area (palm + fingers). This helps patients apply appropriate amounts and prevents overuse.

1. Rule out infection before initiating — Always exclude tinea (especially tinea incognito from prior steroid misuse), scabies, impetigo, or herpes before prescribing potent steroids. Steroid application masks and worsens infections.

1. Avoid the face, flexures, and genitalia — Thin skin in these areas leads to rapid atrophy, striae, and telangiectasia. If absolutely necessary, use only under specialist supervision for shortest duration.

1. 2-week rule for continuous use — Limit continuous application to maximum 2 weeks per course. For chronic conditions, use intermittent/pulse therapy (e.g., weekends only) to minimise adverse effects.

1. Step-down therapy — Once acute inflammation controlled, step down to a mid-potency or low-potency steroid (mometasone, betamethasone valerate, hydrocortisone) for maintenance rather than continuing clobetasol.

1. Taper, don't stop abruptly — For patients using clobetasol regularly, taper frequency (once daily → alternate days → twice weekly) before discontinuing to prevent rebound flare.

1. Beware of FDCs — Fixed-dose combinations with antifungals/antibacterials are extensively misused in India. Use only when coexisting infection confirmed; avoid empirical use of combination products.

topical-corticosteroid; super-potent-steroid; psoriasis; eczema; dermatitis; lichen-planus; scalp-psoriasis; skin-atrophy-risk; HPA-suppression; paediatric-caution; Schedule-H; Clobetasol Propionate

RxIndia v1.0 — 06 Jun 2025

• CDSCO Approved Formulations List

• Indian Pharmacopoeia 2022

• National Formulary of India (NFI) 2021

• IADVL Textbook of Dermatology (Indian Association of Dermatologists, Venereologists and Leprologists)

• IADVL Guidelines for Topical Corticosteroid Use

• AIIMS Dermatology Treatment Protocols

• API Textbook of Medicine (11th Edition)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (14th Edition)

• ICMR Guidelines for Management of Psoriasis

• IAP Drug Formulary (Paediatric Cautions)

• Product package inserts (Tenovate®, Dermovate®)