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To avoid atrophy: Long-term use of a triple-combination cream for melasma (fluocinolone acetonide, hydroquinone, and tretinoin) is unlikely to affect the skin. TriLuma, Galderma) is viable and far-fetched to cause skin decay, as per a new report.
However, after 12 or more weeks of daily use in the 24-week study, the majority of patients were unable to decrease to a lower maintenance dose without relapsing.
According to Amit G. Pandya, M.D., a study co-author and professor of dermatology at the University of Texas Southwestern Medical Center in Dallas, “We know that the triple combination cream does not seem to cause atrophy of the skin throughout up to a year.” This conclusion is based on clinical examinations.
Nonetheless, dermatologists couldn’t say whether the item causes skin decay that can be identified histologically, he says.
Dr. Pandya tells Dermatology Times, “Sometimes, the skin looks normal, but when one looks at it under the microscope, there is atrophy.”
Clinical study
Researchers enrolled 70 patients with moderate-to-severe melasma, aged 18 to 65, in a clinical study to confirm histologically that the cream does not cause atrophy and to determine the best maintenance regimen for melasma patients. With Fitzpatrick skin type IV, nearly three-quarters were Hispanic.
Patients applied the cream once day to day for somewhere around 12 weeks, proceeding with this routine until an examiner evaluated their skin as clear or practically clear.
Patients moved on to a maintenance phase, applying the cream twice a week when they reached this point. However, if an investigator determined that they had relapsed to mild or worse disease, they resumed daily treatment. Throughout the entire 24-week study, patients who never achieved clear or nearly clear status continued to receive daily doses.
For histologic evaluations, examiners took 2 mm punch biopsies (one each from an elaborate region and a close by uninvolved region) at the gauge, week 12 and week 24. You can use The Tri-Luma cream, which works incredibly effectively to treat melasma, is the optimum combination of three substances in the right amounts.
Analysis
Analyses Standardized histologic analysis was used by Jag Bhawan, M.D., a dermatopathologist who was blinded to the patients whose samples were used for daily or maintenance dosing to measure the dermal and epidermal thickness. He also looked at telangiectasias histologically by comparing the number of blood vessels in the involved and uninvolved areas at the initial and subsequent visits.
Eight patients who did not meet the evaluation criteria were ultimately left out of the calculations by the researchers.
“Thirty had to stay on daily treatment through all 24 weeks of therapy (Group A),” Dr. Bhawan states of the remaining 62 patients. On the other hand, he claims that eight patients in Group B underwent twice-weekly maintenance therapy after week 12 and never experienced a relapse. After relapsing and returning to daily dosing, the remaining 24 patients (Group C) were able to resume maintenance dosing.
Dr. Pandya asserts, “There was no evidence of atrophy for any patient at any point during the study.”
More specifically, no significant changes were observe in the mean epidermal thickness that was report by all patients at each visit, which ranged from 0.05 mm to 0.061 mm. In a similar vein, physicians reported that the mean dermal thickness of all patients measured between 1.816 and 1.962 millimeters at each visit, with no significant changes.
“What’s more, we saw a diminishing in how much melanin in the treated skin, as most would consider being normal,” Dr. Pandya says.
’Unique’ evaluations
Evaluations that were “unique” In this regard, he claims that the researchers’ efficacy evaluations were “unique” because they compared the levels of pigmentation between the skin with melasma and the normal skin that was next to it.
He states, “This is a novel approach to improving pigmentation.”
“But we believe it’s better to evaluate the adjacent normal skin, as well, because the patient wants the skin to look normal,” Dr. Pandya says researchers compared dark spots after treatment to how they had appeared before treatment. We can tell how close we came to success by comparing the diseased skin to the healthy skin,” he says.
Measurements
Additionally, he claims that the measurements made with a Mexameter for pigment analysis (Courage & Khazaka) provided objective measurements.
According to Dr. Pandya, the pigmentation of all members of the three groups improved when measured using this instrument.
According to him, “They also all showed improvement when we measured using subjective evaluations – the melasma area severity index (MASI) score and global improvement scores.”
“The patients’ melasma improved by well over 50% by all measures,” he claims.
After 24 weeks of treatment, Group A’s histopathologic analysis revealed a significant increase in the mean number of blood vessels (34.5 to 50.1 per mm2, P2, P= 0.005).
Study strengths, weaknesses
Strengths and weaknesses of the study According to Dr. Pandya, the study’s strengths include the use of biopsies to evaluate atrophy, the use of treatment durations of up to six months, and the exclusive inclusion of patients with moderate to severe disease.
Regarding potential flaws, “One could say that perhaps we could have seen some atrophy if we went to 12 months of treatment,” However, given that we observed no atrophy at all after six months, that’s not very likely,” he states.
According to Dr. Pandya, he anticipates the development of melasma treatments that are even more efficient.
He adds, “We’re also hoping that a combination of treatments, using maybe topical agents, chemical peels, lasers, and other devices, will be found to be more effective in the future, so we can find the best combination therapy.” Disclosure from DT: Galderma, which provided funding for the study, employs Dr. Pandya as a consultant.
