Aclene Plus0.1%+2.5%

Aclene Plus is a fixed-dose combination topical gel indicated for the following use:

• Acne vulgaris (established/approved use): Topical treatment of acne vulgaris in patients, generally for facial and/or truncal (chest, back, shoulders) lesions. The retinoid component (adapalene) normalizes follicular keratinization and has anti-inflammatory effects, while the benzoyl peroxide component provides antibacterial and additional keratolytic action against acne-related bacteria, together targeting both comedonal and inflammatory acne lesions.

There is no well-established evidence base for using Aclene Plus in conditions other than acne vulgaris; it is not indicated for rosacea, other inflammatory dermatoses, or cosmetic skin lightening, and such uses are considered off-label and not recommended without direct physician guidance.

Each gram of Adapalene + Benzoyl peroxide gel typically contains Adapalene (a synthetic retinoid) 0.1% or 0.3% w/w, in combination with Benzoyl peroxide 2.5% w/w, in an aqueous gel base. Strength combinations and excipients vary by manufacturer/brand; check the specific product label for exact composition.

Aclene Plus is a fixed-dose combination topical medication used in dermatology for the treatment of acne vulgaris. It combines a third-generation topical retinoid (adapalene) with an antibacterial/keratolytic agent (benzoyl peroxide) in a single gel formulation, allowing simultaneous targeting of multiple factors involved in acne development, including abnormal follicular keratinization, inflammation, and proliferation of Cutibacterium acnes (formerly Propionibacterium acnes). Aclene Plus is applied once daily to affected skin and is available in different strength combinations for use in adolescents and adults.

Aclene Plus belongs to the therapeutic class of topical anti-acne combination agents, combining a topical retinoid-class drug with a topical antibacterial/keratolytic agent.

Adapalene + Benzoyl peroxide works through two complementary mechanisms:

• Adapalene is a synthetic retinoid analogue that binds to specific retinoic acid nuclear receptors (RAR-beta and RAR-gamma) in the skin. This normalizes the differentiation of follicular epithelial cells, reducing microcomedone formation, and also exerts anti-inflammatory properties by inhibiting inflammatory mediator pathways.
• Benzoyl peroxide is an oxidizing agent with bactericidal activity against Cutibacterium acnes through the release of free radicals/reactive oxygen species that oxidize bacterial proteins. It also has mild keratolytic and comedolytic effects, helping to unblock follicles, and unlike topical/oral antibiotics, does not induce bacterial resistance.

Used together in Adapalene + Benzoyl peroxide, these mechanisms act on complementary steps of acne pathogenesis (keratinization, inflammation, and bacterial proliferation), which is why the combination is often more effective than either agent alone. Systemic absorption of both components through intact skin is minimal under normal use conditions.

Wash the affected area gently with a mild, non-medicated cleanser and pat dry before application. Apply a thin layer of Aclene Plus once daily in the evening, avoiding the eyes, lips, angles of the nose, and mucous membranes. Wash hands after application. Use a broad-spectrum sunscreen and protective clothing during the day, as skin treated with Aclene Plus may be more sensitive to sunlight (see Precautions and Warnings).

Aclene Plus has minimal systemic drug interactions given its topical use and minimal systemic absorption; the interactions of clinical relevance are primarily local/dermatologic:

• Other topical retinoids, peeling or exfoliating agents, and additional benzoyl peroxide-containing products: Concomitant use with other topical retinoids, alpha-hydroxy or salicylic acid preparations, medicated or abrasive soaps, or other benzoyl peroxide products may produce additive skin irritation, dryness, and peeling; such combinations should be avoided unless directed by a physician.
• Topical dapsone gel: Concurrent application of benzoyl peroxide-containing products (including Aclene Plus) with topical dapsone gel has been reported to cause temporary yellow-orange discoloration of the skin and facial hair at the site of application; this is cosmetic and reversible but combined use should generally be avoided.
• Sulfur, resorcinol, or salicylic acid-containing products: May increase local irritation if used together without spacing application times or physician guidance.

The most common adverse effects of Aclene Plus are local skin reactions, which are typically most pronounced during the first few weeks of treatment and tend to decrease with continued use:

• Dryness, scaling, and peeling of the skin
• Erythema (redness)
• Burning or stinging sensation, especially on application
• Skin irritation and, less commonly, contact dermatitis
• Application-site pain or itching
• Transient initial worsening ("purging") of acne appearance may occur in the early weeks of treatment
• Bleaching (discoloration) of hair, fabric, and colored materials that come into contact with the benzoyl peroxide component (a cosmetic, non-systemic effect - see Precautions and Warnings)

Severe allergic reactions (rash, swelling, severe itching, difficulty breathing) are rare; discontinue use and seek medical attention if these occur.

Pregnancy: Data on the use of Aclene Plus in pregnant women are limited. Topical retinoids as a class are generally advised to be avoided or used with caution during pregnancy because oral retinoids are known teratogens, even though systemic absorption of topical adapalene is low. As a conservative measure, Aclene Plus should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should be consulted before use in pregnancy.

Lactation: It is not known whether topically applied adapalene or benzoyl peroxide are excreted in human milk in clinically significant amounts. Because systemic absorption is minimal, risk to a breastfed infant is expected to be low, but caution is advised - avoid application to the chest/breast area if breastfeeding, and consult a physician before use while breastfeeding.

The following precautions apply to the use of Aclene Plus:

• Photosensitivity: Use of Aclene Plus may increase skin sensitivity to sunlight and UV light. Minimize sun exposure, avoid sunlamps/tanning beds, and use a broad-spectrum sunscreen and protective clothing during treatment.
• Local irritation: Significant dryness, redness, burning, and peeling can occur, particularly during the first few weeks. Use a moisturizer as needed and reduce application frequency temporarily if irritation is severe, resuming as tolerated; consult a physician if irritation is intolerable.
• Bleaching effect: The benzoyl peroxide component can bleach or discolor hair, fabric, carpeting, and colored or treated materials. Avoid contact of treated skin with colored towels, clothing, and bedding, and allow the gel to dry fully before contact with fabric.
• Avoid irritant combinations: Do not use concurrently with other topical retinoids, strong peeling/exfoliating agents, medicated or abrasive cleansers, or other benzoyl peroxide-containing products, as this increases irritation without added benefit (see Interactions).
• Avoid sensitive areas: Keep away from the eyes, eyelids, lips, mouth, nostrils, mucous membranes, and open wounds, cuts, sunburned, or eczematous skin.
• Weather extremes: Wind and cold may be additionally irritating to skin treated with Aclene Plus.
• For external/topical use only; not for oral, ophthalmic, or intravaginal use.

Excessive topical application of Aclene Plus does not speed up improvement of acne and instead increases the risk of marked redness, peeling, and discomfort; it should be washed off with mild soap and water if applied in excess. Accidental oral ingestion of Aclene Plus gel (e.g., by a child) or a severe local reaction is not expected to be life-threatening from the small quantities typically used, but if ingestion occurs or a severe reaction develops, seek immediate medical attention or contact a poison control center/emergency services rather than attempting home treatment.

Store at room temperature (below 30°C), away from light and moisture. Keep the tube tightly closed. Keep out of reach of children.

Pediatric patients: See Pediatric Uses below.

Elderly patients: Acne vulgaris is uncommon in the elderly, and specific studies of Aclene Plus in this population are limited; use with the same precautions regarding skin fragility and irritation as in other adults.

Renal or hepatic impairment: No dose adjustment is expected to be necessary given minimal systemic absorption with topical use; however, specific data in patients with significant renal or hepatic impairment are limited, so use with routine caution.

Patients with sensitive or compromised skin (eczema, sunburn, open wounds): Avoid applying Aclene Plus to compromised, eczematous, or sunburned skin due to increased risk of irritation and absorption.

Visible improvement in acne with Aclene Plus is generally seen after several weeks of continuous once-daily use, with maximal benefit typically apparent after 12 weeks of therapy. Treatment duration should be guided by a physician and continued as long as needed to control acne, with periodic reassessment; long-term maintenance therapy may be recommended for chronic acne once initial improvement is achieved.

Topical retinoid (adapalene) combined with a topical antibacterial/keratolytic agent (benzoyl peroxide); classified overall as a topical anti-acne combination agent.

Adapalene + Benzoyl peroxide acts through the combined retinoid receptor-mediated normalization of follicular keratinization and anti-inflammatory activity (adapalene) together with oxidative, bactericidal, and keratolytic activity against Cutibacterium acnes (benzoyl peroxide); see Pharmacology for full detail.

The safety and efficacy of Aclene Plus have been established for the topical treatment of acne vulgaris in adolescent patients within the age range specified on the approved product label (commonly 9 years and older for lower-strength formulations, and 12 years and older for higher-strength formulations, depending on the specific product); consult the specific product labeling for the exact approved age. Safety and efficacy in children below the approved age range have not been established, and Aclene Plus should not be used in younger children without specific physician guidance.