OBAGI - Tretinoin 0.05%

Obagi Tretinoin Cream 0.05% is a prescription topical retinoid containing 0.05% tretinoin in a hydrophilic cream formulation. Each gram contains 0.5 mg of tretinoin. It is supplied in a 20g tube and is indicated for the topical treatment of acne vulgaris.

Tretinoin is also known as all-trans retinoic acid. It belongs to the retinoid class of medicines and is distinct from retinol used in non-prescription cosmetic skincare.

Product information

• Product: Obagi Tretinoin Cream
• Active ingredient: Tretinoin
• Strength: 0.05% w/w, equivalent to 0.5 mg of tretinoin per gram
• Formulation: Hydrophilic topical cream
• Tube size: 20g
• Route of administration: Topical use
• Indication: Acne vulgaris
• Product code: NDC 62032-412-20

Indication

Obagi Tretinoin Cream 0.05% is indicated for the topical treatment of acne vulgaris. Acne vulgaris can include non-inflammatory lesions such as open and closed comedones, commonly described as blackheads and whiteheads, as well as inflammatory papules and pustules.

The manufacturer’s prescribing information states that the safety and efficacy of long-term use for other disorders have not been established. Any use outside the labelled indication must be determined by the prescribing clinician.

How tretinoin works

The exact mechanism responsible for every clinical effect of tretinoin has not been fully established. Current evidence indicates that topical tretinoin reduces the cohesion of follicular epithelial cells, which can decrease the formation of microcomedones. It also increases the turnover of follicular epithelial cells and supports the extrusion of existing comedones.

Tretinoin is a pharmacologically active retinoid medicine. It should not be described as simply exfoliating the surface of the skin or treated as equivalent to an over-the-counter retinol cosmetic.

Understanding the 0.05% strength

A concentration of 0.05% means that each gram of cream contains 0.5 mg of tretinoin. This is not the same as 0.5% tretinoin: a 0.5% formulation would contain ten times the concentration.

Within the Obagi tretinoin cream range, 0.05% is twice the concentration of the 0.025% cream and half the concentration of the 0.1% cream. These figures describe the amount of tretinoin in each formulation. They do not independently determine which concentration is appropriate for an individual.

Cream formulation

Obagi Tretinoin Cream 0.05% uses a hydrophilic cream vehicle. A cream and a gel can contain the same active ingredient and concentration, but their formulation vehicles, inactive ingredients and physical textures are different.

The cream contains stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene and purified water. These ingredients form the cream vehicle and are separate from the active ingredient, tretinoin.

How to use Obagi Tretinoin Cream 0.05%

Use this medicine according to the directions provided with the prescription. The manufacturer’s product information describes application once daily before bedtime, using enough cream to cover the affected area lightly. Individual prescribing directions may differ.

1. Gently cleanse the treatment area with a mild, non-medicated cleanser.
2. Pat the skin dry without scrubbing.
3. Allow the skin to dry completely before applying the cream. The manufacturer’s instructions specify waiting approximately 20 to 30 minutes after cleansing.
4. Apply a thin layer over the affected area.
5. Keep the cream away from the eyes, mouth, corners of the nose, open wounds and mucous membranes.
6. Wash the hands after application unless the hands are being treated.

The manufacturer’s instructions describe approximately half an inch or less of cream as normally sufficient to cover the whole face lightly. The cream should become effectively invisible after it has been spread over the skin.

Using a larger quantity or applying the cream more frequently does not produce faster or better results and may increase irritation.

Expected response during treatment

A temporary feeling of warmth or slight stinging can occur following application. Dryness, redness and peeling may also develop during the early part of treatment.

The manufacturer’s prescribing information states that an apparent increase in inflammatory lesions can occur during the early weeks as previously unseen lesions develop. Its patient information places this most commonly around three to six weeks after treatment begins.

Initial changes may be noticed after two to three weeks, although more than six weeks can be required before definite effects are seen. The manufacturer’s patient information states that many people who respond notice improvement by approximately 12 weeks.

These timeframes describe the manufacturer’s clinical information and do not guarantee an individual response.

Skincare used with tretinoin cream

Cosmetics may be used, but they should be removed and the treatment area cleansed thoroughly before applying tretinoin. A suitable non-comedogenic moisturiser may be used to help manage dryness.

Additional caution may be required with:

• Medicated or abrasive cleansers
• Products with a strong drying effect
• Astringents and products containing high concentrations of alcohol
• Products containing sulphur, resorcinol or salicylic acid
• Other topical acne medicines

Previous topical treatments may continue to irritate the skin after they have been stopped. Product combinations and application timing should follow the prescribed treatment plan.

Sun and environmental exposure

Unprotected exposure to sunlight, sunlamps and other artificial ultraviolet sources should be minimised during treatment. Sunscreen and protective clothing should be used when exposure cannot be avoided.

Do not apply tretinoin to sunburned skin until the skin has fully recovered. Wind, cold and other weather extremes may also increase dryness and irritation in treated skin.

Tolerability and adverse effects

Local skin reactions associated with topical tretinoin can include:

• Dryness
• Redness or erythema
• Peeling or flaking
• Warmth, burning or stinging
• Itching
• Skin discomfort

More pronounced reactions can include excessive redness, swelling, blistering or crusting. Severe or persistent irritation requires clinical review. The product should be discontinued if a reaction suggesting hypersensitivity occurs.

Tretinoin may cause marked irritation when applied to eczematous, damaged or sunburned skin. Temporary increases or decreases in pigmentation have also been reported in treated areas.

Topical retinoids, including tretinoin, should not be used during pregnancy or when planning a pregnancy. Breastfeeding and any possibility of pregnancy should be discussed with the prescribing clinician before treatment.

Clinical information

The current manufacturer information identifies acne vulgaris as the indication for Obagi Tretinoin Cream 0.05%. It describes clinical changes beginning after approximately two to three weeks, with more than six weeks sometimes required before definite effects are apparent and continued improvement potentially occurring over six to twelve weeks.

The manufacturer’s current label does not provide numerical head-to-head trial results establishing that Obagi Tretinoin Cream 0.05% is universally more effective, better tolerated or more appropriate than the 0.025% or 0.1% formulations.

Ingredients

Active ingredient: Tretinoin 0.05% w/w, equivalent to 0.5 mg per gram.

Inactive ingredients: Stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene and purified water.

Storage

The manufacturer’s information states that Obagi Tretinoin Cream should be stored below 27°C (80°F). Keep the tube securely closed and out of the reach of children.

Frequently asked questions

What is Obagi Tretinoin Cream 0.05%?

It is a prescription topical cream containing 0.05% tretinoin, equivalent to 0.5 mg per gram. It is supplied in a 20g tube and is indicated for acne vulgaris.

Is tretinoin 0.05% the same as retinol?

No. Tretinoin is all-trans retinoic acid and is a prescription retinoid. Retinol is a cosmetic vitamin A derivative that must be converted within the skin before becoming retinoic acid. They are not equivalent ingredients or concentrations.

What is the difference between tretinoin 0.025%, 0.05% and 0.1%?

The figures describe the concentration of tretinoin in each gram of formulation. A 0.05% cream contains twice the tretinoin concentration of a 0.025% cream and half the concentration of a 0.1% cream. This does not mean that one concentration is automatically more appropriate than another.

What is the difference between tretinoin 0.05% cream and gel?

Both formulations contain tretinoin at the same stated concentration, but their vehicles and inactive ingredients differ. The formulation and concentration are separate product characteristics and should not be interchanged without clinical direction.

How long does tretinoin 0.05% take to work?

The manufacturer states that initial changes may be noticed after two to three weeks, but more than six weeks may be required before definite effects are apparent. Continued improvement may occur over six to twelve weeks.

Can tretinoin cause more blemishes at first?

The product information describes a possible apparent increase in inflammatory lesions during the early weeks of treatment. This is sometimes informally called “purging”, although that is not the formal medical description used in the product label.

Can moisturiser be used with Obagi Tretinoin Cream?

Yes. The manufacturer recommends a non-comedogenic moisturiser or moisturiser with sunscreen that does not aggravate acne. Moisturiser may also help manage treatment-related dryness.

Can salicylic acid or other acne products be used with tretinoin?

Salicylic acid, sulphur, resorcinol, medicated cleansers and other drying topical products may increase irritation when used with tretinoin. Their use and application timing should follow the prescribed skincare plan.

Is this product indicated for fine lines or pigmentation?

The current product label identifies acne vulgaris as the indication for this particular tretinoin cream and states that the safety and efficacy of long-term use for other disorders have not been established. Any other intended use must be determined clinically.

Further ingredient information

Tretinoin: uses, strengths, formulations and UK status