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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).


See all TRI-Luma indications & dosage >>

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]

more trials >>

Reports of Suspected TRI-Luma (Fluocinolone / Hydroquinone / Tretinoin) Side Effects

Eye Irritation (3)Eye Burns (3)Eye Pruritus (3)Eye Pain (3)Ocular Hyperaemia (3)Accidental Exposure (3)Ochronosis (2)Medication Residue (2)Eye Swelling (2)Skin Odour Abnormal (1)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 14 ratings/reviews, TRI-Luma has an overall score of 4.86. The effectiveness score is 5 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

TRI-Luma review by 40 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   melasma
Dosage & duration:   3 x day (dosage frequency: 1 x day) for the period of 1 month then on and off when spots start
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   excellent!!!! been using on and off for about 5 yrs now. I have learned how this works so theres no side effects such as really dry flaky skin. i use a little in the am then at night.I do this for about 2 wks. Meanwhile i DO NOT use any scrubs or rub my face , just gently, also NO masks or toners etc. Close to 2 wks, when in a hot shower gentle exfoliate, you will see dead skin coming off. dry your face and ts gonna look dry, flaky and terrible. use PURE COCOBUTTER on your face during the day, then only at night use the triluma, and repeat the exfoliate every few days, then the cocobutter etc, until you get results. My face looks amazing after using this process, but i do not have acne, so not sure how it would work with the cocobutter, might make the acne worse. good luck!
Side effects:   dry skin
Comments:   explained above

 

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 33 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Melasma
Dosage & duration:   A little amount (dosage frequency: twice a week) for the period of 4 times
Other conditions:   overall healthy
Other drugs taken:   Nothing
  
Reported Results
Benefits:   I've not got any benefits. I've just spoiled my skin and pigment spots look now dark brown and they are very obvious.
Side effects:   1. Redness; 2. Burning; 3. Red spots; 4. Pigment spots look darker. 5. Skin is very sensitive. I can't put a Sunscreen on at all. 6. Possibility to develop skin cancer! 7. Bad experience for $200!!!
Comments:   Hi! I am a russian (european race) who has migrated from Sweden to the USA. I have developed melasma (dark spots) under my eyes and on my forehead. I visited a dermatologist in the USA, FL about 1 month ago. He prescribed me Tri Luma that contains 4% of Hudroquinone. Have you ever read about Hydroquinone?- I asked him. As I investigated it I found the information that hydroquinone has been banned in many european countries including France, Sweden and Russia etc, for concerns about increased cancer risk.The FDA admitted that the risk of using the drug is not known and more testing needs to be done.In fact, the FDA also warned that hydroquinone has been linked to a condition that disfigures the skin. Anyway,I tried the cream, a sample that the doctor gave to me. He prescribed to use it twice a week - Mondays and Fridays. It was terrible!!! I used it just once a week on my pigment spots because my skin got red, burning and after 1 week it was peeling. Some doctors prescribe to use it once, twice a day!!! I put it on only once a week. Ok, after 1 month, 4 treatments I have the result: my pigment spots have not been improved at all. Moreover, the skin is burnt and now I have very obvious dark red-brown spots. I really look terrible. I can't put on any sunscreen because the skin is damaged by Tri Luma. I am so happy that I didn't buy the full size cream which costs $200 and the insurance doesn't cover it. I don't want to buy cancer for $200. Thanks. I've also contacted russian and swedish doctors. They've forbade to use it strongly!!! They've suggested to use natural products such as juice of lemon, parcley, put camomile teabags on dark spots, oatmeal etc... and of course, avoid the Sun. Please be aware, read more information online.

See all TRI-Luma reviews / ratings >>

Page last updated: 2008-11-03

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