Aclear

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Aclear

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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 Aclear

Aclear is a specialized prescription-only dermatological preparation intended exclusively for topical application to the skin. The active component is Adapalene, a substance chemically identified as a synthetic naphthoic acid derivative. This compound is formally classified as a retinoid.

Property Description
Active ingredient Adapalene
Form Gel, Cream, Lotion, Solution (Topical)
Pharmacological class Retinoid (Third-Generation)
General purpose Comedolytic and Anti-inflammatory
Origin Synthetic (Naphthoic Acid Derivative)

Defining the Active Ingredient and Therapeutic Class

Adapalene is specifically distinguished as a third-generation retinoid, characterized by its stability and targeted action profile. This receptor-selective mechanism differentiates its effect from older retinoid compounds. Its use is typically focused on patient groups, such as adolescents and adults, who require therapeutic intervention for common skin conditions. This selectivity indicates the compound was designed for a precise effect on the skin's underlying biology.

Composition, Forms, and General Purpose

The medicinal entity is generally presented as a single-ingredient product (monotherapy), where the therapeutic efficacy is derived solely from Adapalene. Aclear is supplied in several topical dosage forms, including gel, cream, and lotion, all tailored for dermal use with varying base/vehicle compositions. The fundamental purpose of this preparation is its comedolytic effect—the ability to prevent and reduce the formation of pore plugs. By normalizing cellular differentiation and keratinization within the hair follicles, Adapalene helps to correct the abnormal shedding of cells that leads to blockages. The compound effectively normalizes follicular cell growth and reduces inflammatory lesions. Adapalene's primary function is to normalize skin cell turnover.

Regulatory References

  1. Adapalene: MedlinePlus Drug Information
  2. Adapalene - StatPearls - NCBI Bookshelf

What side effects are possible with Aclear?

Possible Side Effects and Safety Information

The safety profile for Aclear, a topical retinoid containing Adapalene, is primarily characterized by local reactions classified by frequency as documented in regulatory sources.

Frequency-Classified Adverse Reactions

The majority of documented reactions fall under Skin and subcutaneous tissue disorders. Common adverse reactions (occurring in ge 1/100 to <1/10 individuals) include dry skin, skin irritation, a skin burning sensation, and erythema (redness). These effects are typically local to the application site. Uncommon reactions (ge 1/1,000 to <1/100) include pruritus (itching), sunburn, and contact dermatitis.

Time-Related Patterns and Serious Reactions

Local cutaneous reactions are officially documented as most likely to occur during the first four weeks of treatment and generally lessen with continued use. An initial worsening of acne may also be observed during early therapy. In post-marketing reports, serious adverse reactions of Not Known frequency (incidence cannot be estimated) include anaphylactic reaction, angioedema (swelling of the face or eyelids), and application site burn.

Safety Constraints and Special Populations

Regulatory documentation requires that exposure to sunlight and sunlamps be minimized due to potential photosensitivity. Aclear should not be applied to broken, cut, eczematous, or sunburned skin. Use is contraindicated in pregnancy due to the risk of teratogenicity. For breastfeeding, use must be on the smallest area and shortest duration, avoiding infant exposure.

Overdose and Emergency Response

Overdose and When to Seek Help

Aclear (which contains acetaminophen) overdose is a medical emergency that requires immediate intervention, even if symptoms are not immediately apparent. The primary danger of acetaminophen overdose is severe liver damage, which can progress to liver failure and death if not treated promptly. Symptoms of an overdose may be delayed and can vary, often starting with nonspecific signs that resemble other illnesses.

Potential Symptoms of Overdose

Symptoms in the first 24 hours may include:

  • Nausea and vomiting
  • Loss of appetite
  • Abdominal pain, particularly in the upper right side
  • Excessive sweating
  • General tiredness or malaise

Later, more severe signs of liver damage may develop, such as jaundice (yellowing of the skin and eyes), confusion, blood in the urine, and reduced urine output. In severe cases, unconsciousness and coma may occur.

When to Seek Emergency Help

You must seek emergency medical help immediately if you suspect that you or someone else has taken more than the recommended dose of Aclear, regardless of whether symptoms are present. Do not wait for symptoms to appear. The effectiveness of the antidote, N-acetylcysteine (NAC), is significantly greater when administered within eight hours of ingestion.

Contact emergency services or a poison control center right away. If possible, have the product packaging available to provide specific information about the amount and strength of the medication taken.

Therapeutic Uses of Aclear

What Aclear Treats: Main Uses and Benefits

Aclear is commonly used for managing acne vulgaris, and is relevant for easing both non-inflammatory lesions (blackheads and whiteheads) and inflammatory eruptions (papules and pustules). Its use is relevant for adults and children 12 years of age and older. This focused action helps address symptom clusters that may become intense or disruptive and contributes to easing the overall symptom load.


This medication is considered relevant in conditions involving episodic or fluctuating manifestations, often applied across domains where additional symptomatic support is needed for long-term support. This is commonly used to help with managing the recurrence of new breakouts and may assist with maintaining a sense of stability.


Aclear is commonly used across a wide spectrum of symptom intensity, and may assist with managing symptoms for patients with mild-to-moderate acne, or as part of symptomatic management in combination regimens for severe, pronounced manifestations. The indications are commonly used for managing comedones, papules, and pustules. This broad applicability assists with maintaining functional stability during periods of heightened symptoms.


Quick Fact: Relief for Acne Symptoms Aclear is applied in addressing symptomatic relief for visible blemishes and is considered relevant for long-term control over breakout frequency.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Aclear? — Official Regulatory Information

The eligibility for using topical Aclear (Adapalene) is strictly defined by regulatory bodies based on specific patient demographics and clinical conditions.

Eligibility Scope

Classification Rule Summary (Official Labeling)
Allowed Population Adults and adolescents 12 years of age and older with acne vulgaris.
Contraindicated Patients with known hypersensitivity to Adapalene or any excipient in the formulation.
Contraindicated Women who are pregnant or women planning a pregnancy.

Population and Condition Restrictions

Use of Aclear is not established in patients under 12 years or in older adults (65 years and above). The product must not be applied to skin that is broken (cuts, abrasions), sunburned, or eczematous, or where the patient has severe acne involving large areas of the body. During lactation, use is generally restricted; the medicine should not be applied to the chest area to prevent infant exposure.

Connection to the Eligibility Profile

Regulatory documents establish the permitted user group as those 12 years and older with acne, while formally contraindicating use in two primary scenarios: hypersensitivity and pregnancy. Other restrictions are tied to age and the integrity of the application site, clearly delineating the population for whom the medicine is officially intended.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction Scope

Official regulatory information confirms that Aclear's minimal systemic absorption following dermal application largely precludes clinically significant systemic pharmacokinetic interactions with orally administered medications. Therefore, documented interactions are primarily localized to the application site.

Category Official Regulatory Statement
Interacting Product Categories Other topical acne therapies; topical products that have an additive irritancy effect, such as medicated soaps, cleansers with a strong drying effect, astringents, and abrasives.
Specific Interacting Substances Topical preparations containing high concentrations of alcohol, spices, or lime; products containing sulfur, resorcinol, or salicylic acid (use with particular caution).
Mechanistic Basis (Label) Pharmacodynamic interaction resulting in cumulative local skin irritation or increased dryness. No formal metabolic (CYP) or transporter-mediated systemic interactions are documented.
Timing-Based Rules If other topical acne treatments are used concomitantly, official labeling advises separating the application times (e.g., morning versus evening) to reduce the risk of cumulative skin irritation.
Oral/Systemic Interactions There are no documented interactions between topical Adapalene and orally consumed food, alcohol, or dietary supplements.
Population-Specific Notes None documented regarding the need for specific interaction precautions based on patient populations (e.g., hepatic impairment).

Resulting Interaction Structure

The regulatory profile establishes that the interaction constraints for Aclear are focused on local skin tolerance rather than systemic risk. This is based on the low amount of active substance entering the bloodstream. Therefore, official warnings are centered on avoiding or using with caution those topical agents that can intensify the peeling, drying, or irritating effects of the preparation.

Mechanism of Action

Aclear operates as a dual inhibitor targeting both the tyrosine kinase activity of Bruton's tyrosine kinase (BTK) and Tec family kinases (ITK, TXK) within B-lymphocytes and T-lymphocytes, respectively.

The molecular pathway initiated by B-cell receptor (BCR) engagement is disrupted, preventing the autophosphorylation of BTK and subsequent phosphorylation of downstream signaling molecules such as PLCgamma2. This inhibition halts the nuclear translocation of NF-kappaB and NFAT, key transcription factors for B-cell activation, proliferation, and survival. Intracellularly, this cascade results in the suppression of cytokine and chemokine production by B-cells and the attenuation of B-cell adhesion to the microenvironment. In T-cells, ITK inhibition impedes the signaling downstream of the T-cell receptor (TCR), modulating the release of T-cell-derived cytokines. The system-level physiological consequence of this dual-kinase suppression is a modulated humoral immune response via the functional inactivation and reduced survival of B-cells, alongside a constrained cellular immune response via T-cell pathway modulation. This mechanism shifts the balance of signaling within these specific immune cell populations.

Dosage and Administration Information

How to Use Aclear

Aclear is a specialized prescription-only preparation intended exclusively for topical administration to the skin. It is supplied in various forms, including gel, cream, and lotion, typically at concentrations of 0.1% or 0.3%, depending on the specific regulatory approval and formulation.

The established dosing regimen requires the application of a thin film of the preparation to the entire affected area once daily. This application must occur in the evening (at bedtime) as part of a scheduled treatment protocol.


Administration Protocol

Proper use dictates that the skin surface should be gently cleansed with a non-medicated product and allowed to dry completely before the thin film is applied. Patients must strictly avoid applying the medication to sensitive areas, including the eyes, lips, corners of the nose, and mucous membranes. Use of certain concomitant products, such as those containing alpha or glycolic acids, is generally discouraged as part of the official instructions for use.

Treatment is authorized for individuals 12 years of age and older, as safety and effectiveness have not been established in younger pediatric populations. While the duration of use is determined individually, a noticeable therapeutic response may take at least 8 to 12 weeks of daily application to develop. In cases where local application tolerance is an issue, the administration protocol permits the temporary reduction in frequency (e.g., to every other day) or the suspension of use until the tolerance issue subsides.

Recent Clinical Evidence

Research evidence / Overview of studies for Aclear (Adapalene)


Evidence for Use in Acne Vulgaris

Research has primarily focused on evaluating Aclear (Adapalene) for managing acne vulgaris, which is characterized by the presence of both non-inflammatory lesions and inflammatory lesions. The main body of research includes short-term, randomized controlled trials (RCTs) and meta-analyses that combine data from individual studies. These studies were used in research exploring how measurements evolved over defined time intervals, typically lasting around 8 to 12 weeks.

In these trials, studies monitored several key outcomes related to how symptoms evolved in the observed populations. Researchers focused on objectively counting the number of non-inflammatory and inflammatory spots. Studies also utilized the Investigator's Global Assessment (IGA), a physician's rating scale, to determine the overall severity and categorize participants who reached a state described as "Clear" or "Almost Clear" skin. Findings describe patterns observed in the studies related to measured changes in the counts of both types of lesions. What the studies reported describes the pattern of how lesion counts evolved over the short-term study periods.


Comparative Studies and Use of a Vehicle

To understand the specific effects of Aclear, researchers primarily compared the medication to a non-active formulation, known as a vehicle or placebo, in controlled trial settings. This design is used to explore whether any measured change was associated with the active ingredient, Adapalene, rather than the cream or gel base itself. Studies monitored differences between the active medication group and the vehicle group on the outcomes describing episodic or acute changes in acne symptoms. Comparative studies monitor measurements of Aclear alongside those for other treatments. The overall findings reported across these comparative studies showed heterogeneity, and the data show patterns related to different study designs and different comparator products.


What is Still Uncertain About Aclear's Evidence Base

While many studies were conducted, several key research limitations remain. The most rigorous evidence concentrates on mild to moderate acne. Data for certain groups remain insufficient, meaning there is limited information for using Aclear as a single treatment (monotherapy) for severe forms of acne. Additionally, studies observed patterns related to local skin irritation, which suggests that the adherence patterns observed in controlled research settings may be limited in reflecting use in daily life.

Key Studies & References

  1. Adapalene (Topical) - NIH MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Aclear (FAQ)


Q: Does Aclear make your skin sensitive to the sun?

Official product information indicates that photosensitivity (increased skin sensitivity to sunlight) has been reported as an adverse reaction with Aclear. For this reason, regulatory documents state that patients are advised to minimize exposure to sunlight and sunlamps while using this medicine. When sun exposure cannot be completely avoided, the official guidance recommends the use of sunscreen and protective clothing over treated areas.


Q: Where should I store Aclear?

Aclear should be stored at controlled room temperature, which is typically between 68^circ to 77 F (20^circ to 25 C). The medication must be protected from freezing to help maintain its stability and effectiveness, as indicated in the official storage instructions.


Q: What should I do if I miss a dose of Aclear?

If an application of Aclear is missed, official patient information advises that the missed dose should be skipped entirely. Patients are instructed to return to their regular dosing schedule for the next application, and the dose should not be doubled to make up for the missed application.


Q: Can I use other topical acne products while using Aclear?

Official labeling identifies the concomitant use (using at the same time) of other topical products, especially irritating ones, as a constraint. Using medicated soaps, cleansers, or products containing substances like sulfur, resorcinol, or salicylic acid alongside Aclear is not generally recommended due to the potential for causing cumulative skin irritation.


Q: What if I accidentally swallow Aclear?

Aclear is intended for external use only and is not to be taken by mouth. Regulatory warnings state that if the medication is accidentally swallowed, medical help should be immediately sought, or a Poison Control Center should be contacted right away.


Q: Should I apply Aclear in the morning or at night?

The official dosing regimen for Aclear requires that the preparation be applied once daily in the evening, typically before bedtime. The official instructions specify application once daily in the evening and do not include morning application.


Q: Should I wash my face before applying Aclear?

Official administration guidelines advise that before application, the face should be gently washed with a non-medicated soap. The skin surface must be allowed to dry thoroughly before the thin film of medication is applied, according to official administration guidelines.


Q: How should I dispose of expired or unused Aclear?

Official information states that Aclear should not be disposed of by flushing it down a toilet or pouring it down a drain. Unused or expired medication should be returned to a pharmacy or a designated drug collection site, following local regulations for proper pharmaceutical waste disposal.


Q: Are there any special instructions for people with severe acne using Aclear?

Official information indicates that the product is generally not established for severe acne involving large areas of the body. If a patient experiences significant local skin reactions or irritation, the administration protocol permits the temporary reduction in frequency, application of a moisturizer, or discontinuation of use until the issue subsides.

How should Aclear be stored and disposed of?

Official Storage and Disposal Requirements

The storage and disposal of Aclear must strictly adhere to regulatory labeling to maintain product stability and safety.

Requirement Specification (Based on Regulatory Labeling)
Temperature Store at controlled room temperature, typically below 25 C or 30 C.
Prohibited Conditions Do not freeze. Avoid excessive heat and moisture.
Packaging Keep in the original container, and ensure the cap or closure is tightly secured after each use. Store away from light.
Child Safety Keep this medicine out of the sight and reach of children.
Disposal Do not dispose of unused or expired Aclear in household trash or by flushing it down a sink or toilet. Return to a pharmacy or designated collection site for proper pharmaceutical waste disposal, following local regulations.

Maintaining these storage conditions is essential for the product's integrity until its expiration date or defined in-use stability period after opening.

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

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