The sources used here give different time frames for different products, and none of them describes a formal on-off cycle for hydroquinone 8%. The label for Tri-Luma, a fluocinolone acetonide, hydroquinone and tretinoin cream listed in Drugs@FDA at 0.01%;4%;0.05%, states that it is indicated for the short-term treatment of moderate to severe melasma of the face. The same label says it is not indicated for maintenance treatment and that melasma usually recurs upon discontinuation.
What the Tri-Luma label says
Every point in this section comes from the Tri-Luma label (0.01%;4%;0.05%). None comes from a label for hydroquinone 8%.
- The label says the cream is NOT indicated for the maintenance treatment of melasma. After achieving control, some patients may be managed with other treatments instead of triple therapy.
- It says therapy should be discontinued when control is achieved. During the day, a sunscreen of SPF 30 and protective clothing should be used and sunlight avoided.
- Its clinical studies section says remission periods appeared to shorten between progressive courses of treatment. It also says few subjects maintained complete clearing of melasma (approximately 1 to 2%). The statement used here gives no time period for that figure.
Other time frames in the sources
These time frames differ. Each is for a different product, setting or kind of source.
| Source and product | What it says about time |
|---|---|
| Two prescription hydroquinone 4% cream labels: one, an unapproved-drug listing on DailyMed, and the other | If no improvement is seen after 2 months of treatment, use of the product should be discontinued. |
| An expert opinion and literature review by a panel of dermatologists, aimed at Indian patients; it names modified Kligman's formula and gives no strength in the statement used here | Recommended photoprotection and modified Kligman's formula as first-line therapy for up to 12 weeks. In most patients, maintenance therapy with non-hydroquinone products or a fixed triple combination would be needed intermittently, twice a week or less often. |
What two randomized studies report
A randomized, investigator-blinded study compared two maintenance regimens of a triple combination cream containing fluocinolone acetonide, hydroquinone and tretinoin: a twice weekly regimen and a tapering regimen. It was done in people with no or mild melasma after daily treatment. After 6 months, 53% of patients remained relapse-free, and time to relapse was similar between groups (about 190 days). The statement used here gives no strength and compares the two regimens with each other, not with no maintenance.
A randomized study of two versions of the Kligman-Willis triple combination formula, with strict sun protection, in Thai women with melasma reported that twenty-one subjects who were followed up exhibited mild relapse within 2 months after finishing the treatment. Their pigmentation levels remained significantly lower than before treatment. The statement used here gives no strength and describes no comparison group for that follow-up.
What a Cochrane review says about long-term evidence
A Cochrane review of melasma treatments concluded that the quality of studies evaluating melasma treatments was generally poor and available treatments inadequate. It called for high-quality randomised controlled trials on well-defined participants with long-term outcomes to determine the duration of response.
What this does not tell you
No source used here describes a formal on-off cycle for hydroquinone 8%. The sources used here report no trial of hydroquinone 8% or of the blend with tretinoin, niacinamide and vitamin C. The time frames and relapse figures above come from other products, other combinations and expert opinion, so they cannot be assumed to apply to a compounded cream. The label statements are for the named product only. How long a course lasts is a decision for a licensed provider, and this guide does not suggest a length or a schedule.