Skinoclear 15% Gel for External Use 30 g

Indications

• acne of mild to moderate severity, including the presence of papules and pustules;
• rosacea, including the presence of papules and pustules.

Application method and doses

For external use. Before applying the gel, the skin should be thoroughly washed with clean water and then dried, or a mild cleansing cosmetic product should be used. Do not use occlusive dressings. After each application of the gel to the skin, hands should be washed. The gel is applied in a thin layer to the affected areas of the skin twice a day (in the morning and evening), gently rubbing it into the skin (2.5 cm of gel is sufficient for the entire surface of the face).
In children aged 12 to 18 years, the Skinoclear preparation is used for the treatment of acne, and dose adjustment is not required. The efficacy and safety of the preparation in children under 12 years of age for the treatment of acne have not been established. The efficacy and safety of the preparation in children under 18 years of age for the treatment of rosacea have not been established.
It is important that the Skinoclear preparation is used regularly throughout the treatment period. The duration of treatment is individual and depends on the severity of the condition. Improvement usually occurs after 4 weeks of treatment; if necessary, the Skinoclear preparation may be used for several months. If there is no improvement in the treatment of acne after 1 month and no improvement in the treatment of rosacea after 2 months, or if the condition worsens, the use of the Skinoclear preparation should be discontinued and a doctor should be consulted. In case of skin irritation, the amount of gel applied each time should be reduced or the frequency of application should be decreased to once a day. A short-term discontinuation of the preparation may be possible, followed by resumption after the symptoms of irritation have disappeared at the recommended dose. Use the preparation only according to the method of application and in the doses specified in the instructions. If necessary, please consult a doctor before using the medicinal product.

Section: Composition

100 g of gel contains:
Active ingredient: azelaic acid - 15.0 g.
Excipients: propylene glycol - 12.0 g, polysorbate-20 - 1.5 g,
carbomer 980 - 1.0 g, isopropyl myristate - 1.0 g, sodium hydroxide - 0.2 g, benzoic
acid - 0.1 g, disodium edetate dihydrate - 0.1 g, ceramides LS - 0.1 g, water - up to 100.0 g

Opaque homogeneous gel from white to yellowish-white color

Section: Contraindications

• hypersensitivity to azelaic acid and other components of the drug;
• age under 12 years (acne), under 18 years (rosacea).

With caution
Bronchial asthma.

Special instructions

For external use only. Avoid contact of the gel with eyes, mouth, and other mucous membranes. In case of accidental contact with mucous membranes, including eyes and mouth, rinse them with plenty of water. If eye irritation persists, consult a doctor. After each application of the product, wash your hands. During treatment with Skinoclear for rosacea, it is recommended to refrain from using cosmetic products containing alcohol, alcoholic solutions, astringents, abrasive or exfoliating agents (for peeling).

The Skinoclear product contains propylene glycol, which may irritate the skin, and benzoic acid, which mildly irritates the skin, eyes, and mucous membranes. During post-marketing surveillance, there have been rare reports of exacerbation in patients with bronchial asthma with the external use of azelaic acid.

The most common side effects observed in clinical studies and during post-marketing surveillance were: itching, burning, and pain at the application site. The side effects listed below are classified according to the following frequency gradations (according to the World Health Organization (WHO) classification): very common (≥ 1/10); common (≥ 1/100, but < 1/10); uncommon (≥ 1/1000, but < 1/100); rare (≥ 1/10000, but < 1/1000); very rare (< 1/10000); frequency unknown (cannot be estimated based on available data). Disorders of the immune system Frequency unknown: hypersensitivity reactions (including angioedema, eye swelling, facial swelling, shortness of breath), exacerbation of bronchial asthma. Skin and subcutaneous tissue disorders Uncommon: contact dermatitis, acne** (pimple rash). General disorders and administration site reactions Very common (at the application site): itching, burning, pain; Common (at the application site): dryness, rash, paresthesia, swelling**; Rare (at the application site): erythema (redness), desquamation* (peeling of the epidermis), warmth sensation*, depigmentation (discoloration) of the skin, discomfort**, urticaria**; Frequency unknown: skin irritation, urticaria. *- for acne; **- for rosacea. If any of the side effects listed in the instructions worsen, or if you notice any other side effects not mentioned in the instructions, inform your doctor.Overdose phenomena with external use have not been established.InteractionClinically significant interactions with the use of the Skinoclear drug have not been identified.

Section: Pharmacodynamics

Azelaic acid normalizes the disrupted keratinization processes in the follicles of sebaceous glands during acne therapy and also reduces the content of free fatty acids in the skin lipids. It exhibits antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. The mechanism of action of azelaic acid in rosacea is unknown. It can be assumed that the anti-inflammatory effect is due to a reduction in neutrophil metabolism and a decrease in their production of reactive oxygen species. Azelaic acid exerts a dose- and time-dependent inhibitory effect on the growth and viability of abnormal melanocytes.

Pharmacokinetics

Absorption
After application to the skin, azelaic acid penetrates the epidermis and dermis, with penetration occurring faster in damaged skin than in intact skin. After a single external application of 5 g of 3.6% gel, 3.6% of the total dose of azelaic acid enters the systemic circulation.
Elimination
A portion of the absorbed acid is excreted by the kidneys in unchanged form, while part is excreted as dicarboxylic acids (C7, C5) formed as a result of beta-oxidation.

Description

Skinoklir 15% is a gel for external use that effectively addresses various skin issues: acne, inflammation. Due to its composition, the drug has antimicrobial action (primarily against Propionibacterium acnes and Staphylococcus epidermidis) both on the skin surface and in the sebaceous glands, as well as anti-inflammatory action.

The gel has a light consistency and absorbs quickly, leaving no greasy stains on the skin. It is suitable for people with different skin types. The gel can be used for the treatment of acne and rosacea.

Skinoklir comes in a convenient 30-gram tube that can be taken anywhere. The application of the gel is very simple: a small amount should be applied to the problematic area of the skin and gently massaged in. Repeat the procedure two to three times a day until complete recovery.