Urea Treatment for Dry and Rough Skin

Overview

Urea is a topical emollient used as a moisturizing, keratolytic, and antipruritic agent, and it plays an important role in keratinocyte gene regulation. One of the first uses of Urea was the topical treatment of wounds due to its proteolytic and antibacterial properties. Currently, Urea is widely used in dermatology. It is prescribed for treating diverse dermatoses presenting scaly and dry skin, such as seborrheic dermatitis (skin conditions that cause a scaly rash on the scalp and face), atopic dermatitis (skin condition that causes itchy, dry, and inflamed skin), ichthyosis (a group of skin disorders characterized by dry, scaly or thickened skin), and psoriasis (a condition in which skin cells build up and form scales and itchy, dry patches). Furthermore, Urea can also increase skin penetration and optimize topical drugs' action.

Dosage Form:

Urea comes in different forms, such as-

• Cream (10%, 20%, 30%, 35%, 40%, 41%, 45%, 50%).

• Lotion (10%, 20%, 30%, 35%, 40%, 41%, 45%, 50%).

• Gel (40%, 45%, 50%)

• Suspension ( 40%, 50%).

• Solution (50%).

• Ointment (10%, 20%, 50%).

• Emulsion (40%, 45%, 50%).

• Aerosol, foam (20%, 30%, 35%, 40%, 42%).

What Is the Clinical Use of Urea?

Urea is indicated for hyperkeratotic conditions, such as-

• Dry and rough skin.

• Xerosis (abnormally dry skin).

• Ichthyosis (a condition that causes widespread and persistent thick, dry, fish-scale skin).

• Skin cracks and fissures (cracks in the skin that typically occur in areas that get dry, thick, or calloused, such as the heels).

• Dermatitis (skin irritation).

• Eczema (a condition that causes dry, itchy, and inflamed skin).

• Psoriasis (askin disease that causes a rash with itchy, scaly patches, most commonly on the knees, elbows, trunk, and scalp).

• Keratoses (dry scaly patches of skin that have been damaged by the sun).

• Calluses (thick, hardened layers of skin that develop when the skin tries to protect itself against friction or pressure).

Warnings and Precautions:

• Urea 35% topical foam is for external use only and should not be used in the ophthalmic, oral, anal, or intervaginal area.

• Contact with eyes, mouth, and nose should be avoided.

• Urea should not be used by people with known hypersensitivity reactions to Urea or any ingredients in the Urea.

• The medication should be used as directed by the physician.

• The medication should not be used to treat any other condition other than that it is prescribed for.

• If any side effect occurs, discontinue using it and consult with the prescribing physician.

Use in Specific Population:

• Pregnancy - Animal reproduction studies have not been performed in topical Urea, and it is not known if it can cause fetal harm when administered to pregnant patients. However, Urea should be used with caution during pregnancy.

• Lactation - It is unknown how Urea can affect lactation. Due to the fact that many drugs are excreted in human milk, hence pregnant and breastfeeding should seek the advice of a healthcare professional before using Urea.

• Children - It is not advisable for children below the age of 12 years as the safety and efficacy data is unavailable. Although, if necessary, it should be consulted with a physician.

Drug Interactions:

Urea has no known serious interactions with other drugs. However, it can have mild to moderate interactions with collagenase and vasopressin.

For Patients:

What Is Dermatitis?

Dermatitis is the medical term used to describe extremely dry skin, which can be caused due to a variety of reasons. Dermatitis can be of different types, such as-

• Contact Dermatitis - It is caused when the skin touches something it is allergic to and develops inflammation.

• Seborrheic Dermatitis - In this condition, the skin produces too much oil causing a red and scaly rash, usually on the scalp.

• Atopic Dermatitis - It is commonly known as eczema and is a chronic skin condition that causes dry and scaly patches on the skin.

Why Is Urea Prescribed?

Urea works as a moisturizer to treat dry and rough skin conditions. It is also used to prevent itchiness and other skin irritations. Urea softens the dry patches that are caused by certain skin conditions such as eczema, psoriasis, fungal nail infections, foot corns, etc.

How Should Urea Be Used?

Urea is available in many different forms, and the following instructions should be followed while using Urea-

• It should be used exactly as described on the label or as directed by the physician.

• It should not be used in smaller or larger doses or longer than recommended.

• Apply the medication one to three times a day or as directed by the physician.

• It should not be taken by mouth as it is a topical agent used only on the skin or scalp.

• If the medication goes into the eyes, nose, mouth, or any area not recommended to apply, it is advisable to rinse properly with water.

• Clean the area with water and/or mild soap before applying the Urea.

• Apply a thin layer of Urea on the affected area properly.

• Allow the Urea to dry properly on the affected area.

• Other forms of Urea that come in foam or solution forms should be shaken before use.

• Wash hands properly after applying the medication.

What Precautions Should Be Taken?

• The doctor should be informed about any prescription, non-prescription, or over-the-counter medication the patient takes.

• The patient should inform the doctor about any dietary supplements or herbal products they use.

• Pregnant or breastfeeding patients should inform about their conditions.

• If the patient has a prior history of side effects with Urea, it should be informed.

• If the patient is allergic to any other medication, they should inform the doctor.

• If the patient has any medical condition, then they should inform the doctor.

• The patient should make a written list of all the medications they are taking in case of emergencies.

What Are the Side Effects of Urea?

• Burning.

• Itching.

• Redness.

• Rash.

• Stinging sensation.

• Unusual skin changes like blistering or peeling.

• Signs of skin infection.

Storage and Disposal:

• Urea should be kept at room temperature and away from heat and moisture.

• Do not freeze it.

• Close the lid properly when not in use.

• The foam canister should be kept away from the heat source as it can explode if exposed to too much heat.

What Should Be Done if the Dose is Missed?

• The person should use the missed dose as soon as they remember.

• The missed dose can be skipped if it is almost time for the application of the next dose.

• Do not apply extra medicine to make up for the missed dose.

What Should Be Done in Case of Overdose?

In case of an overdose, seek medical attention or contact the poison control helpline number immediately.

For Doctors:

Indications:

• Maintaining Healthy Skin - Urea with 2 to 20% concentration is used for routine care in individuals without skin conditions.

• Atopic Dermatitis - In atopic dermatitis, the skin is characterized by transepidermal water loss and the dysfunction of the skin barrier. Urea decreases transepidermal water loss and improves the stratum corneum's hydration and water-binding capacity in eczematous skin. Urea concentrations ranging from 4 to 20 % can be used.

• Xerosis - It is frequently seen in diabetic patients, which increases the risk of skin infection and ulceration. Xerosis in elderly and hemodialyzed patients is very common, and concentrations ranging from 5 to 40 % can be used.

• Ichthyosis - Urea concentrations ranging from 2 to 10% are frequently used to treat ichthyosis.

• Psoriasis - Urea concentration ranging from 40 to 50% can improve the hydration of the stratum corneum and water retention capacity and decrease the transepidermal water loss, desquamation, and hyperkeratosis in psoriasis.

• Hyperkeratosis - Urea concentrations of more than 30% can be used to treat the abnormal thickening of the skin in palms and soles characterized in hyperkeratosis.

• Irritation-Induced Dermatitis - It is the most common side effect of radiotherapy and can be treated with the intensive use of lotion containing 3% urea concentration and Polidocanol and hyaluronic acid.

• Seborrheic Dermatitis- Urea has antifungal and antimicrobial properties with high moisturizing capacity and keratolytic effect, which can prevent scaling or rusting in seborrheic dermatitis. The use of a formulation containing 40% urea and 1% Bifonazole may be used in severe cases.

• Actinic Keratosis - Urea concentrations at 40% can be used to treat this condition.

• Nail Disorders - Urea concentration of 40 to 50% can be used to treat nail disorders which enhances nail permeability and softens the nail palate.

Clinical Pharmacology:

Urea dissolves in the skin's intercellular matrix, which enhances the shedding of dry and scaly skin and thereby softens the hyperkeratotic areas of the skin. When used in the nail plate, Urea has the same effect on the intercellular matrix of the nail plate.

Mechanism of Action:

Urea is known to increase the moisturization of the stratum corneum and also water retention. It reduces the transepidermal water loss and enhances the resistance of the stratum corneum against the osmotic stress. Urea acts as an endogenous humectant, replacing water in low-humidity conditions. It regulates epidermal proliferation by decreasing the DNA synthesis in basal cells and prolonging the generation time of post-mitosis epidermal cells. Urea increases the gene expression of the antimicrobial peptide, cathelicidin, and beta defensin-2 and augments mRNA and protein levels of transglutaminase-1, involucrin, loricrin, and filaggrin. The ketolytic action of Urea denatures keratin either by breaking its hydrogen bonds or by inducing conformational changes in its protein structure. Urea facilitates the transport of molecules such as antifungals, corticosteroids, and hormones through the skin and nails.

Pharmacodynamics:

Urea is a keratolytic emollient that treats or prevents dry, rough, scaly, and itchy skin.

Administration:

• It is indicated to rub the lotion or cream on the affected area until absorbed properly.

• The medication should be applied two to three times a day.

• The doctor should inquire about prior history of side effects with Urea or any other topical applicant.

Percentage of Urea

Clinical Evaluation:

Urea 35 % was evaluated in a water lipid base foam delivery system containing lactic acid in participants with mild to moderate xerosis of the foot. The aim of the study was to determine the safety and efficacy of Urea in the treatment of xerosis. Six diabetic and six nondiabetic patients with the clinical diagnosis of xerosis were enrolled in the study for four weeks and monitored at baseline and final visits.

Method:

• Each participant was given a canister containing the study medication, and instructions were given to apply it in the morning and evening with twelve hours gaps after properly cleaning the affected area.

• Participants were instructed to discontinue or not use any other prescription or non-prescription topical creams or ointments on the affected area, with a two-week washout period for topical products used for xerosis of the feet.

Evaluation:

Conclusion of the Clinical Investigation:

All the participants who completed the study experienced an improvement in xerosis. The investigator and participants observed significant improvement in redness, scaling, and cracking from baseline to the end of treatment. Hence, 35 % urea in a water-lipid–based foam delivery system containing lactic acid can be used as an appropriate treatment option for mild-to-moderate xerosis of the foot.

Caution:

• Ischemic skin necrosis has been reported with high concentrations.

• Not for use near the eye area.

• Urea may increase the absorption of ingredients in other products patients might be using, and if they are sensitive to those other products, Urea may make the reaction worse.

Contraindications:

• Hypersensitivity.

• Viral skin disease.