The prescribing information for Tri-Luma (fluocinolone acetonide, hydroquinone and tretinoin cream) states that the cream is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. Its Drugs@FDA record lists the strengths as 0.01%;4%;0.05%. Everything below is about that approved cream. It is a different product from a compounded hydroquinone 8% cream.
What the label says the cream is for, and its limits
An FDA drug safety communication states that Tri-Luma is currently the only FDA-approved drug containing hydroquinone. The label describes its ingredients as fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor) and tretinoin (a retinoid). It also states limits.
The cream is not indicated for maintenance treatment of melasma, and melasma usually recurs upon discontinuation. The label states that remission periods appeared to shorten between progressive courses of treatment, and that few subjects maintained complete clearing of melasma (approximately 1 to 2%).
Safety and efficacy in patients of Fitzpatrick Skin Types V and VI have not been studied, and excessive bleaching in patients with darker skin cannot be excluded. The label describes two adequate and well-controlled trials in 641 subjects aged 21 to 75 years, with Fitzpatrick skin types I-IV. Safety and efficacy in hyperpigmentation conditions other than melasma of the face have not been studied.
Directions and when to stop
The label directs applying a thin film to the affected area once daily, at least 30 minutes before bedtime. It says therapy should be discontinued when control is achieved. During the day it directs a sunscreen of SPF 30, protective clothing and avoiding sunlight exposure. The patient information leaflet says to avoid sunlight, sunlamps, tanning beds and ultraviolet light during treatment. These are directions for this one product. A licensed provider decides the directions for any other product.
Warnings on the label
- Ochronosis. The label warns that the cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, and that its occurrence should prompt discontinuation of therapy. A separate prescription hydroquinone 4% skin bleaching cream label says to discontinue treatment and consult a physician if it occurs.
- Irritation. The label states that hydroquinone and tretinoin may cause mild to moderate irritation, and that skin reddening, peeling, mild burning sensation, dryness and pruritus may be expected at the site of application.
- Sulfite and hypersensitivity. The cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible individuals. It is contraindicated in individuals with a history of hypersensitivity to the product or any of its components.
- Animal studies. The label states that studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity, and that the carcinogenic potential of hydroquinone in humans is unknown.
Adverse events in the controlled trials
The label says that in the controlled clinical trials, adverse events were monitored in the 161 subjects who used the cream once daily during an 8-week treatment period. There were 102 (63%) subjects who had at least one treatment-related adverse event. The most frequently reported events were erythema, desquamation, burning, dryness and pruritus at the site of application, and the majority were mild to moderate in severity. Table 1 of the label covers treatment-related adverse events in at least 1% or more of subjects (N=161).
| Adverse event | Subjects, n (%) |
|---|---|
| Erythema | 66 (41%) |
| Desquamation | 61 (38%) |
| Burning | 29 (18%) |
| Dryness | 23 (14%) |
| Pruritus | 18 (11%) |
| Acne | 8 (5%) |
The label adds that in an open-label trial, subjects who had cumulative treatment of melasma with the cream for 6 months showed a similar pattern of adverse events as in the 8-week studies.
What this does not tell you
This is one product's label. FDA states that compounded drugs are not FDA-approved, which means FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. The label statements, warnings and adverse event rates above are for Tri-Luma (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%). They cannot be assumed to apply to a compounded hydroquinone 8% cream or to a blend with tretinoin, niacinamide and vitamin C, and the sources used here report no trial of either. The adverse event figures describe the 161 subjects who used the approved cream, not other creams. A licensed provider decides whether any product is suitable for a person.