TRI-Luma (Fluocinolone Acetonide / Hydroquinone / Tretinoin) - Summary

TRI-LUMA SUMMARY

TRI-LUMA^® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) contains fluocinolone acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a hydrophilic cream base for topical application.

TRI-LUMA^® Cream is indicated for the short-term intermittent treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.

The following are important statements relating to the indication and usage of TRI-LUMA^® Cream:

• TRI-LUMA^® Cream, a combination drug product containing corticosteroid, retinoid, and bleaching agent, was proven safe for the intermittent treatment of melasma, with cumulative treatment time of at least 180 days. Because melasma usually recurs upon discontinuation of TRI-LUMA^® Cream, patients can be re-treated with TRI-LUMA^® until melasma is resolved. Patients need to avoid sunlight exposure, use sunscreen with appropriate SPF, wear protective clothing, and change to non-hormonal forms of birth control, if hormonal methods are used.
• In clinical trials used to support the use of TRI-LUMA^® Cream in the treatment of melasma, patients were instructed to avoid sunlight exposure to the face, wear protective clothing and use a sunscreen with SPF 30 each day. They were to apply the study medication each night, after washing their face with a mild soapless cleanser.
• The safety and efficacy of TRI-LUMA^® Cream in patients of skin types V and VI have not been studied. Excessive bleaching resulting in undesirable cosmetic effect in patients with darker skin cannot be excluded.
• The safety and efficacy of TRI-LUMA^® Cream in the treatment of hyperpigmentation conditions other than melasma of the face have not been studied.
• Because pregnant and lactating women were excluded from, and women of child-bearing potential had to use birth control measures in the clinical trials, the safety and efficacy of TRI-LUMA^® Cream in pregnant women and nursing mothers have not been established PRECAUTIONS, Pregnancy).

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NEWS HIGHLIGHTS

Published Studies Related to TRI-Luma (Fluocinolone / Hydroquinone / Tretinoin)

A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma. [2008.09]
BACKGROUND: Melasma is an acquired, chronic hypermelanosis for which therapy remains a challenge. OBJECTIVES: To compare the efficacy and safety of a triple combination [TC: fluocinolone acetonide 0.01%, hydroquinone (HQ) 4%, tretinoin 0.05%] vs. HQ 4% after 8 weeks of treatment of moderate to severe facial melasma in Asian patients... CONCLUSIONS: Efficacy in Asians and patient satisfaction were superior with the fixed TC than with HQ 4%.

A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma. [2008.06.28]
Background Melasma is an acquired, chronic hypermelanosis for which therapy remains a challenge... Conclusions Efficacy in Asians and patient satisfaction were superior with the fixed TC than with HQ 4%.

A comparison of triple combination cream and hydroquinone 4% cream for the treatment of moderate to severe facial melasma. [2007.03]
The aim of this study was to compare the efficacy and safety of a triple combination (TC) cream and monotherapy with hydroquinone (HQ) cream in the treatment of moderate to severe facial melasma. A total of 120 patients applied TC cream once daily or HQ cream twice daily for 8 weeks...

A large 12-month extension study of an 8-week trial to evaluate the safety and efficacy of triple combination (TC) cream in melasma patients previously treated with TC cream or one of its dyads. [2005.09]
This was a 12-month extension of a randomized, investigator-blinded, multicenter, 8-week trial with triple combination (TC) cream in facial melasma. A total of 585 patients were enrolled in the study and 569 patients received study medication.

Efficacy and safety of a new triple-combination agent for the treatment of facial melasma. [2003.07]
Treatment of melasma, a hyperpigmentation disorder, remains a challenge. The primary objective of two 8-week, multicenter, randomized, investigator-blind studies was to compare the efficacy and safety of a hydrophilic cream formulation containing tretinoin 0.05%, hydroquinone 4.0%, and fluocinolone acetonide 0.01% (RA+HQ+FA) with the dual-combination agents tretinoin plus hydroquinone (RA+HQ), tretinoin plus fluocinolone acetonide (RA+FA), and hydroquinone plus fluocinolone acetonide (HQ+FA)...

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Clinical Trials Related to TRI-Luma (Fluocinolone / Hydroquinone / Tretinoin)

Treatment w/ TriLuma® Cream & Intense Pulsed Light vs a Mild Inactive Control Cream & Intense Pulsed Light in Melasma [Recruiting]
This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide 0. 01%, hydroquinone 4%, tretinoin 0. 05%); TLC) when used sequentially with a series of intense pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a 10 week treatment period.

Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma [Recruiting]
Melasma is an acquired, symmetric, irregular hypermelanosis on sun-exposed areas of the face, commonly seen in Latin American women. It is a very frequent disease, although its true incidence is unknown.

Melasma has historically been difficult to treat and therapy remains a challenge for this chronic condition.

Melasma being a relapsing disease, there is a real need to address how to maintain efficacy achieved after acute treatment. A previous 12-month trial has shown that Tri-Luma® applied once daily over a long-term period is safe and tolerable. However, there are no robust data available either on the efficacy of Tri-Luma® in long-term treatment or guidance for a maintenance dosage regimen with this product.

Investigations have been made through a feasibility work among Dermatologists from USA and Latin America to assess their current practice in terms of Maintenance Therapy. Two regimens appear to be prescribed frequently and will be compared in this study.

The expectation is that Tri-Luma® will be effective, in one of the two regimens explored, in maintaining the Melasma improvement achieved with a previous treatment of Tri-Luma®.

Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma [Completed]
To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a series of Glycolic Acid peels in treatment of moderate to severe melasma.

Efficiency And Safety Of Association Arbutin, Triamcinolone And Tretinoin In Treatment Of Melasma [Not yet recruiting]

Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma [Completed]

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PATIENT REVIEWS / RATINGS / COMMENTS

TRI-Luma review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		acne, melasma
Dosage & duration:		4% hydroquinone .05% tretinoin (dosage frequency: once, at bedtime) for the period of 6 weeks
Other conditions:		none
Other drugs taken:		birth control, synthroid
		Reported Results
Benefits:		lightning of dark pigments
Side effects:		some dry skin especially under eye area
Comments:		Applied once at night as directed. Applied sunscreen in morning of SPF 30. Some dark pigmentation was lightened significantly but some places didn't lighten enough to go unnoticed. Acne was not helped, suprisingly, but the treatment did not make it worse either. Overall skin appearance looked more uniform.

TRI-Luma review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		melasma
Dosage & duration:		1% (dosage frequency: nightly) for the period of 1 month
Other conditions:		fine lines and wrinkles
Other drugs taken:		none
		Reported Results
Benefits:		After pregnancy my upper lip remainedmarked with dark spots - melasma. My Dermatologist prescribed Tri-Luma cream to lighten the spots and also said it would help redice the appearance of my wrinkles.
Side effects:		A few days after use my skin started peeling where I had been using the cream. The cream had an unpleasant odor.
Comments:		After pregnancy my upper lip remainedmarked with dark spots - melasma. My Dermatologist prescribed Tri-Luma cream to lighten the spots and also said it would help redice the appearance of my wrinkles. I used the cream each night. The texture was thick and the smell was not appealing. A few days after use my skin started peeling where I had been using the cream. The peeling was annoying as I would constantly have to put moisturizer on to stick the skin back down. After a month of dilligent nightly usage I did not notice a lightening of my dark spots nor any reduction in my wrinkles. Perhaps with continued use my spots would have lightened but honestly, I couldn't stand walking around with skin peels hanging off my face. The Dr should have advised me about the peeling. I was very dissappointed as this prescription cream cost $100.

TRI-Luma review by 23 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Melasma
Dosage & duration:		1 dime sized dot (dosage frequency: daily) for the period of 7 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		My melasma improved considerably, which speaks to the efficacy of the treament because I only used it for 7 days.
Side effects:		My skin started flaking all over my face (not just on the application sites). The flaking is similar to normal dry skin symptoms. I also developed very minor scabby areas below my eyes, just above the cheek application site. The corners of my mouth turned red and became irritated, which was annoying and unbecoming.
Comments:		I basically bought Tri Luma to treat a cosmetic issue. It helped relieve the problem a bit, but it created additionaly cosmetic problems. I am more embarrassed by the redness at my mouth than I am by the discoloration...actually, I don't know which is worse. I do not know if I would recommend the product to those with normal skin, but I would definitely not recommend it to those with sensitive skin.