Coal Tar 5% | Salicylic Acid 6% | Clobetasol Propionate 0.05%

Route: Topical application to affected skin (scalp, body plaques) as directed by the prescriber.

• Apply a thin layer to affected plaques as directed—typically once or twice daily.
• For scalp psoriasis, part hair and apply directly to the scalp; do not apply to uninvolved skin.
• Do not use under occlusion (bandages, plastic wrap) unless specifically directed—occlusion markedly increases clobetasol systemic absorption.
• Avoid application to the face, intertriginous areas, and mucous membranes unless expressly prescribed.
• Wash hands after application unless the hands are the treatment area.
• Coal tar has a characteristic odor and may stain clothing and surfaces.

Prescriber-determined based on body surface area, disease severity, and prior treatment response:

• Typically applied once to twice daily to affected areas.
• Due to clobetasol's superpotency, use is generally limited to 2 consecutive weeks per treatment cycle, with reassessment before continuation or transition to a lower-potency agent.
• Maximum recommended clobetasol exposure: 50 g/week to minimize HPA axis suppression risk.
• Prescriber determines duration, frequency, and total body surface area limits.

• Coal Tar (5%): The exact mechanism is not fully elucidated. Proposed mechanisms include: suppression of DNA synthesis and inhibition of keratinocyte mitosis (reducing psoriatic epidermal turnover from ~4 days to more normal ~28 days); correction of aberrant keratinocyte differentiation; direct antipruritic effects via suppression of cutaneous nerve fiber stimulation; antimicrobial properties relevant to seborrheic dermatitis.
• Salicylic Acid (6%): Dissolves the cementing proteins between corneocytes in the stratum corneum, reducing intercorneocyte adhesion and facilitating desquamation. In psoriasis, removes the thick parakeratotic scale that limits drug penetration, allowing coal tar and clobetasol to reach viable keratinocytes and dermis.
• Clobetasol Propionate (0.05%): Binds cytoplasmic glucocorticoid receptors; the activated complex enters the nucleus and modulates gene transcription: increases anti-inflammatory proteins (lipocortin/annexin-1, inhibiting phospholipase A2 and reducing prostaglandin/leukotriene production), reduces pro-inflammatory cytokine (IL-1, IL-6, TNF-α) transcription via NF-κB suppression, produces vasoconstriction in superficial dermis, and inhibits epidermal keratinocyte mitosis.

This triple-agent combination targets the key pathophysiologic features of plaque psoriasis: hyperproliferation (coal tar, clobetasol anti-mitotic), inflammation (clobetasol), and mechanical barrier of scale (salicylic acid keratolysis). Salicylic acid pre-treatment or co-formulation substantially improves penetration of corticosteroids through psoriatic plaques. The combination is especially useful for thick, scaling, treatment-resistant plaques.

Prescriber monitoring:

• HPA axis suppression: ACTH stimulation test if clinical signs of systemic corticosteroid excess emerge.
• Skin atrophy, striae: limit use duration and avoid sensitive areas.
• Blood pressure and glucose monitoring in patients with hypertension or diabetes.
• Avoid application near eyes (cataract and glaucoma risk).
• Coal tar: carcinogenicity concern with prolonged occupational exposure; clinical topical use at 5% is generally considered acceptable short-term.

Contraindications:

• Hypersensitivity to clobetasol, coal tar, or salicylic acid
• Active skin infections at application site (bacterial, fungal, viral)
• Rosacea, perioral dermatitis, or acne (relative contraindication for clobetasol on face)
• Primary skin atrophy

Warnings & Precautions:

• Clobetasol HPA axis suppression: do not use on large body surface areas continuously; limit to 2 weeks per treatment course without reassessment; maximum 50 g/week.
• Skin atrophy, striae, telangiectasias, and purpura with extended use.
• Coal tar photosensitization: avoid direct sun exposure on treated areas immediately after application.
• Salicylate toxicity with application to large areas (especially children): avoid extensive application in pediatric patients.
• Do not use on the face, groin, or axillae without specific prescriber direction (clobetasol superpotency).

Drug Interactions:

• Clobetasol may interact with live vaccines and immunosuppressants at systemic absorption levels.
• Salicylic acid: additive salicylate effect if patient is on systemic salicylates; monitor.

Common Side Effects: Local burning, pruritus, erythema, skin thinning; folliculitis; striae; coal tar odor and staining; increased photosensitivity (coal tar); rare—HPA axis suppression, Cushing syndrome with prolonged superpotent steroid use.

Store at controlled room temperature (20–25°C / 68–77°F). Protect from heat and light. Do not freeze. Coal tar preparations may require protection from oxidation; keep tightly sealed. Use before the beyond-use date assigned by Genesis Compounding. Keep out of reach of children.

Why does this cream smell like coal tar?

Coal tar is a complex mixture of polycyclic organic compounds with a distinctive petroleum-like odor. The characteristic smell is a normal property of the formulation. Applying the preparation at bedtime and covering treated areas with clothing can minimize odor impact during the day.

Can I use this on my face?

Generally, this formulation is not recommended for the face. Clobetasol propionate is a superpotent corticosteroid that carries significant risk of skin atrophy, steroid rosacea, and telangiectasias with facial use. Application to the face should only occur if specifically directed by your prescriber.

How long can I use this preparation continuously?

Clobetasol-containing preparations should generally not be used for more than two consecutive weeks without prescriber reassessment due to risks of HPA axis suppression and skin atrophy. Your prescriber will guide you on appropriate treatment cycles and transition to maintenance therapy.

Is this product FDA-approved?

No. This is a 503A compounded topical preparation from Genesis Compounding for a specific patient. Individual ingredients (clobetasol 0.05%, coal tar, salicylic acid) have established commercial precedent in psoriasis treatment; this combination at these exact concentrations is a patient-specific compounded preparation.

Will coal tar stain my clothes or skin?

Yes—coal tar can stain fabric, hair, and skin. Use older clothing and bedding when applying to large areas, and allow the preparation to dry before dressing. Wash treated skin gently; staining on skin typically fades with continued bathing.