Alphosyl

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Alphosyl

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Alphosyl

What is Alphosyl?

Alphosyl is a medicated dermatological treatment formulated to manage chronic skin conditions characterized by scaling and overactive skin cell production. It is primarily used to treat psoriasis, including scalp psoriasis, and other forms of dermatitis such as seborrheic dermatitis.

Therapeutic Composition

The active ingredient in Alphosyl is coal tar extract. Coal tar belongs to a class of medications known as keratoplastics. It works by breaking down keratin, a protein that forms part of the skin's structure. In conditions like psoriasis, the skin produces cells at an accelerated rate, leading to the formation of thickened, scaly patches. Coal tar helps to slow this process, reducing the excessive growth of skin cells and assisting in the removal of accumulated scales.

Mechanism of Action

Alphosyl exerts its effects through several mechanisms:

  • Keratolytic Action: It helps soften and loosen crusts and scales on the surface of the skin, making them easier to remove.
  • Antiseptic Properties: It possesses mild antimicrobial qualities that can help prevent secondary infections in affected areas.
  • Anti-Pruritic Effect: It helps to soothe the skin and relieve the itching (pruritus) often associated with chronic inflammatory skin conditions.

Available Formulations

Alphosyl is typically available in topical forms designed for different areas of the body:

  • Alphosyl 2-in-1 Shampoo: A medicated shampoo and conditioner combination specifically designed for the treatment of scalp psoriasis and dandruff.
  • Alphosyl HC: A formulation that may include additional ingredients for more complex inflammatory responses, though the primary focus remains the management of scaly skin disorders.

By targeting the underlying acceleration of skin cell turnover, Alphosyl helps to normalize the skin's appearance and reduce the physical discomfort associated with plaque buildup.

Regulatory References

  1. About the European Medicines Agency (EMA)
  2. About the National Institutes of Health (NIH)
  3. NIH PubMed Review

What side effects are possible with Alphosyl?

Possible Side Effects and Safety Information

The safety characteristics of Alphosyl, a topical preparation containing coal tar and allantoin, are defined by local reactions and specific safety constraints outlined in official regulatory documentation.

Adverse Reaction Classification

Side effects are primarily classified as local skin reactions. The most consistently documented effects relate to the application site, including skin irritation, a burning sensation, folliculitis (inflamed hair follicles), and acne-like eruptions. These are generally categorized under Skin and Subcutaneous Tissue Disorders in official System-Organ Classes.

Frequency Classification Examples of Documented Reactions
Rare Allergic skin rash, photosensitivity, alopecia areata
Very Rare Bronchospasm (in sensitive individuals)
Not Known General hypersensitivity, eye irritation, dermatitis, temporary hair colour changes

Regulatory Safety Considerations

The official safety profile highlights the inherent photosensitivity risk associated with coal tar preparations. Increased sensitivity to sunlight or UV light may persist for up to 24 to 72 hours after the product has been used. Additionally, regulatory documents note that irritation may become more noticeable with prolonged use.

Specific constraints are placed on use in vulnerable populations and certain skin states. The product is restricted or advised against for use in children under 12 years old, and official labels generally recommend avoiding use during pregnancy and lactation. Furthermore, use is formally contraindicated on skin that is acutely inflamed, broken, infected, or affected by acute pustular psoriasis. The possibility of temporary staining of the skin and hair is also noted in regulatory information.

Overdose and Emergency Response

The regulatory documentation for this topical preparation (Alphosyl, containing Coal Tar and Allantoin) focuses the primary risk of overdose on accidental oral ingestion, rather than excessive application to the skin. Topical overuse is generally not expected to be dangerous. Swallowing the medication, however, may lead to systemic effects, which are officially documented to include gastrointestinal signs such as vomiting and stomach irritation.

The most severe documented outcomes following ingestion are acute manifestations requiring immediate emergency intervention. These critical symptoms include trouble breathing and passing out (loss of consciousness). For these serious manifestations, regulators strictly mandate that immediate medical attention must be sought by calling emergency services (e.g., 911). Otherwise, for guidance on accidental swallowing, the individual must call a Poison Control Center right away.

Management of a documented overdose situation relies on procedural interventions. Official regulatory information states that treatment is strictly symptomatic and supportive care. This management may include procedures such as potential gastric lavage, depending on the quantity ingested. No specific chemical antidote is described in the regulatory prescribing information for this product.

Therapeutic Uses of Alphosyl

The primary therapeutic use of Alphosyl is commonly used for managing symptomatic relief of certain chronic skin disorders, specifically those characterized by persistent flaking and scaling. The preparation is considered relevant in contexts involving inflammatory or irritative processes, where additional symptomatic support is needed for these chronic skin conditions.

It is commonly used to help with conditions characterized by periods of heightened symptoms, including scalp psoriasis and severe forms of seborrhoeic dermatitis (dandruff), and is applied in scenarios where additional management of discomfort is required. The preparation helps address symptom clusters that may become intense or disruptive, specifically by assisting with the removal of adherent, thick crusts and helping with managing the build-up of scales.

“Alphosyl is relevant for easing symptoms related to inflammatory or irritative states such as localized itchiness and discomfort.”

This action supports day-to-day comfort during symptomatic periods and helps maintain a sense of stability when symptoms are more noticeable.


Quick Fact: Relief for Persistent Scaling
Alphosyl is relevant for easing symptoms related to scaling and flaking, and supports general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Alphosyl

This section outlines the officially documented population eligibility rules and contraindications for Alphosyl, strictly as defined by government regulatory documents.

Category Official Regulatory Status
Populations for whom use is allowed Adults and adolescents (over 12 years of age) are the standard labeled population for use in chronic scalp conditions like psoriasis and seborrhoeic dermatitis.
Populations for whom use is contraindicated Individuals with known hypersensitivity (allergy) to coal tar extract or any other ingredient. Pregnant women in the first trimester.
Age-related eligibility rules Restricted use in children under 12 years; use must be with caution and only on the advice of a doctor or pharmacist.
Condition-specific eligibility rules Use is prohibited on infected, open, or damaged skin. It is also contraindicated for treating sore or acute pustular psoriasis.
Pregnancy and lactation eligibility status Prohibited during the first trimester of pregnancy. Conditional use in later pregnancy and while breastfeeding, requiring professional consultation, and for breastfeeding, all product residue must be washed off.

Official regulatory documents define eligibility primarily through absolute contraindications concerning allergies, the integrity of the application site, and the first stage of pregnancy. Eligibility for certain groups, such as children under 12, is governed by conditional restrictions that mandate professional oversight.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation defines the interaction profile of Alphosyl, a topical preparation containing Coal Tar and Allantoin, primarily based on the recognized properties of the coal tar component. Due to the product's minimal systemic absorption, official labels typically document an absence of systemic pharmacokinetic interactions with other medicinal products.

Pharmacodynamic Interaction: Photosensitizing Agents

Category Interacting Substances Regulatory Description
Clinically Significant Medicinal products that induce photosensitivity (e.g., Methoxsalen, Aminolevulinic acid, Porfimer). Additive effect increasing the risk of a phototoxic reaction (enhanced sensitivity to light).

The core documented interaction is a pharmacodynamic additive effect with medicines recognized as photosensitizing agents. Co-administration of Alphosyl with these products can significantly enhance the skin's sensitivity to natural sunlight or artificial ultraviolet (UV) light sources. This restriction extends to the requirement to avoid UV exposure after application, a constraint directly correlative to the photosensitizing interaction.

No known interactions with food, alcohol, or herbal products are explicitly documented in regulatory labels for this topical preparation.

Mechanism of Action

Alphosyl, which contains coal tar, exerts its effects primarily within the epidermal layer of the skin. The mechanism of action is polycomponent and remains partially characterized, but current understanding centers on its constituents, such as polycyclic aromatic hydrocarbons, acting as agonists of the Aryl Hydrocarbon Receptor (AHR), a cytosolic transcription factor. Upon ligand binding, AHR translocates to the nucleus and heterodimerizes, initiating the transcription of target genes, including those involved in cellular differentiation and xenobiotic metabolism, such as the cytochrome P450 family. Intracellularly, this activation cascade is linked to the inhibition of DNA synthesis and mitotic activity in hyperproliferative keratinocytes. This molecular intervention modulates the abnormal cell cycle progression in the basal and suprabasal layers of the epidermis. Furthermore, coal tar has been demonstrated to interfere with the signaling of inflammatory cytokines, specifically by inducing the dephosphorylation of STAT6, potentially via AHR-regulated activation of the NRF2 antioxidative stress pathway. The system-level physiological consequence of this dual-action mechanism is a normalization of keratinocyte maturation and turnover rate, alongside a reduction in localized cellular inflammation within the affected cutaneous tissue.

Dosage and Administration Information

How to Use Alphosyl: Administration Guidelines

This section outlines the instructions for using Alphosyl Medicated Shampoo for its 5% w/w Coal Tar formulation. Adherence to these guidelines is important for the correct administration of the product, as specified by the product labeling.


Administration Scope

Category Instruction
Route of Administration Topical use only, applied externally to the scalp and hair.
Dosing Schedule Use a sufficient amount of shampoo to create an adequate lather to cover all affected areas. The wash process requires two full applications per use.
Frequency The standard regimen is to use the shampoo once or twice a week.
Preparation The hair must be thoroughly wetted with water before the first application is made.
Course Duration The recommended treatment course is for four weeks. If symptoms persist or fail to improve after this period, consult a healthcare professional.

Age-Specific Use and Procedural Steps

Population Guidance

Age Group Administration Rule
Adults and Adolescents (12 Years and over) Standard regimen applies.
Children (under 12 Years) Use only with caution and on the advice of a doctor or pharmacist.

Application Sequence

Administration requires a two-step sequence to ensure proper scalp contact:

  1. Preparation: Wet the hair thoroughly with water.
  2. First Application: Apply the shampoo, lather, and gently massage the scalp and adjacent areas with the fingertips.
  3. Rinse: Rinse the hair thoroughly with water.
  4. Second Application: Repeat the application and rinsing steps (Steps 2 and 3).

This procedural structure is designed to achieve the required contact time of approximately three to five minutes over the course of the two applications, as instructed by the product labeling.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Alphosyl

This section provides an overview of the research that has explored the use of topical preparations containing Coal Tar, the primary active ingredient in Alphosyl, for chronic scaling conditions. This summary focuses only on what the scientific literature has studied and described, using neutral language.


Evidence for Use in Chronic Scalp Psoriasis and Severe Seborrhoeic Dermatitis

The research structure for topical Coal Tar preparations includes various forms of scientific evaluation and analysis that explore its use in conditions characterized by excessive scaling, pruritus (itching), and inflammation in these two primary chronic conditions. The discussion focuses on the study designs and the primary findings researchers sought to measure.

Studies monitored populations consisting mainly of Adults with varying degrees of symptom severity, focusing on how symptoms change over defined time intervals. Researchers sought to measure changes in objective clinical signs such as the amount of scaling and plaque thickness, as well as patient-reported outcomes describing the perceived discomfort and levels of pruritus. The research landscape is characterized by evidence that is broadly categorized as Moderate.


Short-Term Study Durations and Primary Outcomes Examined

The clinical trials that form the core of the evidence are generally characterized by a Short-term follow-up, typically tracking participants over periods ranging from approximately four to twelve weeks. These research periods are relevant in trials assessing short-term or episodic symptom patterns.

Key outcomes related to physical discomfort were studied, including measurements of erythema (redness) and the overall severity of the affected area. Studies also examined patient-reported symptoms linked to inflammatory or irritative states, such as how itch intensity was described by the patient population. Reported outcomes were short-term, reflecting the specific conditions under which these studies were conducted.


Long-Term Data and Follow-Up Studies

Research into the effects of continuous or extended use over long periods is limited. Limited data are available for long-term outcomes, which are not well characterized in the structured research, such as formal Randomized Controlled Trials (RCTs). Data for assessing recurrence or the course of the condition following the cessation of use are still emerging, meaning the certainty remains low regarding outcomes extending over many months or years.


Key Limitations and Research Gaps

There is a documented need for more recent, large-scale, placebo-controlled RCTs specifically testing the modern, refined combination product (Coal Tar with Allantoin). A limitation is that many existing studies used other active topical treatments as comparators, rather than a neutral, non-active vehicle. Furthermore, the sample sizes were modest in some of the studies exploring the effects of the combination formulation.

Key Studies & References Coal tar: uses and assessment of safety (NIH PubMed Review)

Frequently Asked Questions (FAQ)

Common questions about Alphosyl (FAQ)


Q: Is it possible for Alphosyl to cause hair to feel dry or brittle?

A: Official product information indicates that a possible side effect of using Alphosyl is abnormal hair texture. While the shampoo contains conditioner, users should be aware of this potential effect. This is often associated with the product's primary action on the hair and scalp, which can sometimes lead to dryness.

Q: Can Alphosyl be used on color-treated, bleached, or grey hair without causing discoloration?

A: Official regulatory information warns that Alphosyl can cause temporary changes to hair colour. It may specifically discolor blond, bleached, or tinted hair. Due to this risk, people with chemically treated or grey hair may wish to proceed with caution.

Q: Is there a risk of Alphosyl staining my clothing, towels, or bedding?

A: Yes, the product label explicitly states that the shampoo can stain skin and clothes. The labeling advises users to rinse the hair thoroughly to help prevent this staining.

Q: Can Alphosyl be used for seborrhoeic dermatitis on other areas of the body besides the scalp?

A: Regulatory documents consistently describe the product for the topical management of conditions that primarily affect the scalp, such as scalp psoriasis and seborrhoeic dermatitis. Its intended use is focused on the scalp area.

Q: Are there different formulations of Alphosyl, such as a lotion or cream, or is it only a shampoo?

A: The specific product for which official regulatory information is available is labeled as Alphosyl 2 in 1 Medicated Shampoo. While other coal tar formulations may exist on the market, the commonly available version is the shampoo.

Q: What should I do if my scalp irritation seems to get worse after using Alphosyl?

A: The official product label advises that if your scalp becomes irritated or if your symptoms worsen while using the product, you should stop using the shampoo. Consultation with a healthcare professional is advised for further guidance.

Q: Is it normal to feel a mild burning or tingling sensation when first applying Alphosyl?

A: A burning sensation of the skin is listed on the product label as a possible side effect. If this sensation is severe or persistent, seeking advice from a healthcare professional is appropriate.

Q: How often do most people need to use Alphosyl to keep their condition under control?

A: After the initial treatment period, the typical recommendation for managing conditions like common dandruff is to use the shampoo once or twice a week as necessary. For severe or persistent conditions, professional guidance on frequency should be followed.

Q: If I miss a wash with Alphosyl, should I double up on the next one?

A: The product label advises that if a wash is forgotten, the user should just apply the next day instead. The label advises against attempting to use extra shampoo to make up for the missed application.

Q: Does the '2-in-1' in Alphosyl mean I don't need a separate conditioner?

A: The product is explicitly labeled as Alphosyl 2 in 1 Shampoo and is described on the packaging as containing conditioner. This indicates the formulation is designed to cleanse and condition the hair simultaneously.

Q: Why do some users report unusual hair thinning or hair loss after using coal tar shampoos?

A: Unusual hair loss or thinning is listed on the product label as a possible side effect of the shampoo. If this is noticed while using the product, consultation with a healthcare professional is recommended.

Q: Does the inclusion of 'parabens' in some Alphosyl formulations pose a health concern?

A: The label contains a warning regarding ingredients such as propylhydroxybenzoate and methylhydroxybenzoate (parabens). The official statement is that these substances may cause allergic reactions, which could be delayed.

Q: Can the herbal fragrance in Alphosyl cause skin irritation for sensitive individuals?

A: The product does contain a herbal fragrance and lists general allergic reactions as a possible side effect. Individuals with known sensitivities to fragrances may want to be mindful of this potential risk.

Q: Is Alphosyl considered safe for long-term or maintenance use after the initial treatment period?

A: If your symptoms persist after the recommended initial course of treatment, the product label advises consulting a doctor or pharmacist. Consultation with a healthcare professional is recommended for decisions regarding ongoing long-term use.

Q: Do you need to leave Alphosyl on the scalp for a certain amount of time for it to work?

A: Yes, the product label specifies that the shampoo should be in contact with the scalp for a total time of three to five minutes over the course of the two required applications. This contact time is important for the active ingredient to be effective.

Q: Is it normal for a coal tar shampoo to be slightly drying on the hair strands themselves?

A: The product label lists abnormal hair texture as a possible side effect. This, along with the potential for skin irritation/dryness, is often related to the product’s therapeutic effect, which may cause some degree of dryness to the hair strands.

Q: Does Alphosyl contain alcohol, and does this contribute to the drying effect?

A: Yes, the product’s active ingredient is formulated as an Alcoholic extract of coal tar. The presence of alcohol may be one factor contributing to the shampoo's potential drying effects on the skin and hair.

Q: If my scalp condition returns, can I safely start a new four-week course of Alphosyl?

A: If your scalp condition persists or returns after the recommended initial treatment, the official label advises consulting a doctor or pharmacist. Consultation with a healthcare professional is advised to discuss re-treatment protocols.

Q: Does Alphosyl work by moisturizing the scalp or by reducing cell turnover?

A: The active ingredient works primarily as an anti-scaling agent that helps break down keratin and slows down cell production. This mechanism addresses the underlying cause of scaling, rather than functioning as a primary moisturizer.

How should Alphosyl be stored and disposed of?

How to Store and Dispose of Alphosyl

The storage and disposal of Alphosyl Medicated Shampoo are governed by official regulatory requirements to maintain product quality and public safety.

Storage Requirements

Alphosyl must be stored at a temperature below 25 °C and should be protected from frost and direct sunlight. The container must be kept tightly closed in a dry place.

Storage Constraint Requirement
Maximum Temperature Store below 25 °C
Light and Moisture Protect from light and store in a dry place
Child Safety Keep out of the sight and reach of children
In-Use Stability Use within 5 weeks after first opening

Disposal Requirements

Expired or unused product must be disposed of according to local regulations for pharmaceutical waste. The product must not be emptied into drains, and its release to the environment should be avoided.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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