Clinical Research Directory

COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA

Melasma is a common acquired hyperpigmentation disorder that significantly affects quality of life. Various topical agents are used in its treatment, including Vitamin C and Niacinamide, both of which possess depigmenting properties. This randomized controlled trial aims to compare the efficacy of topical Vitamin C and topical Niacinamide in patients with melasma. A total of 100 patients will be enrolled and randomly allocated into two groups. Treatment efficacy will be assessed using the Melasma Area and Severity Index (MASI) score after 12 weeks of therapy. The findings of this study may help determine the more effective topical treatment option for melasma.

New Treatment in Melasma

This randomized controlled trial aims to compare different therapeutic approaches for the treatment of melasma. Participants will be randomly allocated into three treatment groups receiving modified Kligman formula, microneedling-assisted topical tranexamic acid, or nanotechnology-based topical tranexamic acid. The study will compare these treatment approaches over a defined treatment period followed by a follow-up period. The study will provide evidence regarding the comparative efficacy and safety of these therapeutic modalities in patients with melasma.

Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial Melasma

Melasma is a common, long-lasting pigmentation disorder of the face. Some patients improve well with treatment and others improve little, and there is no simple way to predict this at the first visit. Recent studies suggest that melasma with more visible blood-vessel involvement may respond less well to treatment. This study will assess whether the amount of vascular involvement seen on dermoscopy before treatment is associated with melasma severity after 12 weeks of oral tranexamic acid. Adults with facial melasma (Fitzpatrick skin types III-V) attending the Department of Dermatology, Allied Hospital-I, Faisalabad, will take oral tranexamic acid 250 mg twice daily for 12 weeks, with a standard sunscreen and a plain moisturiser. Melasma severity (mMASI) will be scored at baseline and at weeks 4, 8 and 12. A dermoscopic vascular score will be recorded at baseline and week 12.

Randomized Split-Face Controlled Study to Evaluate the Effectiveness of Topical Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% as Compared to Topical Tretinoin 0.05% + Hydroquinone 4% + Fluocinolone 0.01% for the Treatment of Melasma

The purpose of this study is to find out whether a new combination cream containing eflornithine, hydroquinone, and fluocinolone works better and causes fewer side effects than Tri-Luma® (tretinoin, hydroquinone, and fluocinolone), a commonly used treatment for melasma. The main question is whether replacing tretinoin in Tri-Luma® with eflornithine leads to greater improvement in melasma and less skin irritation over a 12-week period.

Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser

Melasma is a frequently acquired hyperpigmentary disorder affecting up to 30% of child-bearing women in some populations. Melasma is still often called chloasma or the pregnancy mask and is considered as the main consequence of female hormone stimulation on a predisposed genetic background but only 20% of pregnant women are affected. The investigator hypothesize that the Aerolase laser treatment could not only enhance the efficacy of the topical depigmenting agents but also by reducing the vascular component decrease the intensity of the relapses. All patients applied to the entire face the cosmetic depigmenting agent Mela B3 (La Roche Posay) cream twice daily for 3 months. One session of laser on one side of the face (randomly assigned for each patient for the duration of the study) will be performed every other week for 12 weeks for a total of 6 sessions. All the patients will apply the entire face a sunscreen of sun protection factor 50 with high UVA protection (UV Mune 400; La Roche Posay) during the entire study duration.

Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration

Melasma is a refractory skin disease due to its complex pathogenesis and difficult treatment. Studies have found that human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) could serve as a novel cell-free therapeutic strategy in regenerative and aesthetic medicine. It could potentially treat melasma, but the skin barrier is a challenge. This study aims to explore the safety and efficacy of hUCMSC-Exos in the treatment of melasma and means to promote its percutaneous penetration.

Oral Tranexamic Acid Plus Triple Combination vs Triple Combination Alone in Melasma

The data will be collected after the permission of the ethical committee of hospital. Following the enrollment, patients will be selected by lottery in the two equal groups. Group A will be administered with oral tranexamic acid and triple combination therapy whereas Group B will be treated with triple combination therapy. Strict use of sunscreens and sun protection will be promoted to all patients. Group A will administer oral tranexamic acid with the prescribed dose of the study drug along with topical application of fluocinolone acetonide, hydroquinone and tretinoin at bedtime. Group B will be treated by triple combination therapy only once a day at night. The study will continue to treatment. There will be a baseline MASI score which will be taken prior to the onset of treatment and re-evaluated at the planned follow-ups. The main outcome will be the decrease in the MASI score and the percentage of the patients who will be responding to treatment. The negative effects and recurrence in the follow-up will be considered as secondary outcomes. The structured proforma will gather data on age, gender, melasma duration, skin phototype, baseline MASI score, treatment group, follow-up MASI score, percentage improvement, adverse effects and treatment response. The principal investigator will document all the findings.

Efficacy and Safety of a Combined Topical Formula Versus Placebo in Patients With Melasma

The goal of this clinical trial is to learn whether a topical formulation containing 12% azelaic acid and 5% tranexamic acid is effective and safe for treating melasma in adults. The main questions it aims to answer are: Does the topical formulation reduce melasma severity compared with placebo after 4 weeks of treatment? Is the topical formulation safe and well tolerated? Researchers will compare the active topical formulation with a placebo cream to determine whether the active treatment provides greater improvement in melasma severity and quality of life. Participants will: Be randomly assigned to receive either the active topical formulation or a placebo cream. Apply the assigned treatment daily for 4 weeks. Attend scheduled clinical visits for assessment of melasma severity using the Melasma Area and Severity Index (MASI), quality of life using the Melasma Quality of Life Scale (MelasQoL), and standardized facial imaging with the VISIA® skin analysis system. Be monitored for local adverse events throughout the study.

A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants

The study aims to evaluate the efficacy of a facial sunscreen under two experimental conditions-untinted and tinted-in improving facial spots (melasma and solar lentigines/post-inflammatory hyperpigmentation) after 8 weeks of product use under normal conditions by adult participants.

Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea

This clinical study will evaluate the efficacy and safety of microfocused ultrasound treatment in patients with facial pigmentary diseases and rosacea. The study includes two independent disease cohorts: a facial pigmentary disease cohort and a rosacea cohort. Participants in each cohort will be randomly assigned to receive either active microfocused ultrasound treatment or sham stimulation. Sham stimulation will follow the same treatment procedure as active treatment but will not deliver effective therapeutic ultrasound energy. Participants will receive one treatment session per month for 6 months and will be followed for up to 12 months. The study will assess changes in clinical severity scores, digital skin imaging parameters, patient-reported symptoms, quality of life, and safety outcomes, including adverse events.

Efficacy of New Trio Combination for Melasma

The goal of this clinical trial is to learn if the drug New Trio Combination (0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone) works to treat melasma. It will also learn about the safety of drug. This drug lowers the pigmentation severity by measuring modified Melasma Area and Severity Index (mMASI) reduction by up to 50%. The possible side effects of this drug are erythema and burning. We will compare this drug to kligman's formula (5% hydroquinon, 0.1% retinoic acid and 0.1% dexamethasone) to see if New Trio Combination works to treat melasma patients. All subjects will be divided in two groups. Group 1 will receive New trio combination (NT) and group 2 will receive Kligman's formula (KG), once daily (night time application) for 3 months. Patients will be called for follow up at 4, 8 and 12 weeks. A total of 56 patients fulfilling the inclusion criteria are enrolled in the study. Efficacy of New Trio Combination versus Kligman's Formula will be measured in all selected patients suffering from melasma by estimating improvement in the modified MASI score and MELASQoL at each follow up.

A 4-week Study Investigating Two Targeted Brightening Serum (A and B) Versus 4% Hydroquinone in Women With Mild to Severe Full-face Hyperpigmentation

This a short four-week pilot study to measure the efficacy and tolerance of two brightening serums (cosmetics) versus 4% hydroquinone. The study was conducted in two sites across the USA, one in PA and in one in CA. The goal was to run the pilot study in the summer to understand the role of these two potential brightening serums in helping the appearance of skin tone evenness.

Comparative Efficacy of Intralesional Tranexamic Acid Versus Mandelic Acid Peel in the Treatment of Melasma

Melasma is a chronic acquired disorder of facial hyperpigmentation that significantly affects quality of life. Both intralesional tranexamic acid and mandelic acid chemical peels are effective treatment options with favorable safety profiles in darker skin types. However, comparative evidence in South Asian populations is limited. This study aims to compare the efficacy, safety, quality of life outcomes, and patient satisfaction of intralesional tranexamic acid versus mandelic acid peel in patients with facial melasma treated at Combined Military Hospital Abbottabad.

Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser

More than aesthetics, the search for orofacial harmonization treatments has increased when the negative emotional impact of some facial conditions such as melasma and acne scars is recognized. This study will evaluate the effects of chemical peels with 35% TCA (trichloroacetic acid) and two types of fractional laser in orofacial harmonization procedures. A sample of 100-120 participants at least 18 years of age, male or female, with complaints of melasma (n=36 to 40), acne scars (n=36 to 40) or facial wrinkles (n=36 to 40) will be recruited to underwent 3 consecutive treatment sections every 30 days. Besides clinical improvements, global satisfaction scale of the professional and the patient will be measured in addition to the impact of the treatment on the quality of life of the participants and the sensory experience in relation to pain. Pre- and pos-peeling home care will be provided to measure whether they influence results or not. The aim of this study is to identify the most appropriate treatment strategy for frequent complaints in clinical practice, and among them, the one that promotes the best experience, with the shortest recovery time and is cost-effective.

Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma

Melasma is a chronic acquired hyperpigmentation disorder that commonly affects the face and has a significant impact on quality of life. Available treatments may improve pigmentation, but relapse is common and response can be variable. This randomized split-face interventional study aims to compare the efficacy and safety of injectable platelet-rich fibrin (i-PRF) versus intradermal tranexamic acid (TA) in the treatment of facial melasma. Adult female patients with bilateral symmetrical facial melasma will be enrolled. In each participant, one side of the face will be randomly assigned to receive i-PRF and the contralateral side will receive intradermal TA. Patients will undergo five treatment sessions at 2-week intervals. Clinical response will be assessed using the modified Melasma Area and Severity Index (mMASI), Antera 3D camera measurements, Physician Global Assessment, patient satisfaction, and Melasma Quality of Life (MelasQoL) questionnaire. Safety will be evaluated by recording adverse events such as pain, tenderness, erythema, swelling, infection, ecchymosis, and hematoma. The study is designed to determine whether i-PRF is an effective and safe treatment option for melasma compared with intradermal tranexamic acid.

Clinical Efficacy and Mechanisms of a Topical Azone-Tranexamic Acid-Aloe Polysaccharide Gel in the Treatment of Melasma

Melasma is a common pigmentation disorder among young and middle-aged women, characterized by symmetrical brown-black patches on the face. It is related to genetics, ultraviolet radiation, endocrine factors and inflammation, and can lead to psychological problems and affect quality of life. Current treatments such as hydroquinone stimulation, laser therapy, and oral tranexamic acid have a high recurrence rate and poor compliance. The new gel formulation, which combines tranexamic acid (to inhibit tyrosinase), aloe polysaccharides (anti-inflammatory and repair), and lauric azon (promotes penetration), is expected to enhance efficacy and reduce side effects. This study aims to explore its clinical efficacy and synergistic mechanism, providing new strategies for the treatment of Melasma.

Comparison Between Efficacy of Topical Tranexamic Acid Vs Topical Ethyl Ascorbic Acid In Treatment Of Melasma

This study is to compare the efficacy of topical tranexamic acid vs topical ethyl ascorbic acid in the treatment of melasma

Comparative Evaluation of Topical Metformin and Topical Tranexamic Acid in Melasma

This randomised controlled trial aims to compare the efficacy of topical metformin (30%) and topical tranexamic acid (3%) in the treatment of melasma using reduction in the Melasma Area and Severity Index (MASI) score over 12 weeks. Melasma is a common hyperpigmentation disorder with significant cosmetic and psychological impact, and current treatments often have limitations. Both metformin and tranexamic acid have shown promising depigmenting effects through different mechanisms. A total of 70 patients will be enrolled and randomly divided into two groups. Participants will apply the assigned treatment once daily along with sunscreen and will be assessed at baseline and at 4, 8, and 12 weeks. The primary outcome is MASI score reduction, while secondary outcomes include patient-reported improvement and safety. This study seeks to provide comparative evidence for safer and more effective treatment options for melasma management.

Comparative Evaluation of Topical 30% Metformin and Kligman's Regimen in Women With Melasma

It's a prospective, randomised, assessor-blinded clinical study comparing topical 30% metformin with Kligman's regimen for melasma in women aged 35-55 years at Fauji Foundation Hospital, Rawalpindi. The study seeks to ascertain which treatment yields a more significant decrease in the modified MASI score over an 8-week period and which treatment is associated with fewer adverse effects, such as erythema, burning, peeling, and post-inflammatory hyperpigmentation. A total of 82 participants will be enrolled and randomly assigned to either metformin cream or Kligman's regimen, with both groups also using sunscreen. Assessments will be done at baseline, week 4, and week 8 through mMASI scoring, photographs, and side-effect monitoring. Data will be analyzed in SPSS 26 using t-tests and chi-square testing. The study is based on evidence suggesting metformin may offer comparable efficacy with better tolerability.

Evaluation of the Efficacy of Oral Tranexamic Acid and Glutathione-assisted Microneedling in Treatment of Melasma

In this study, the investigators evaluate the potential efficacy of TXA alone and microneedling assisted with glutathione alone versus combination of oral tranexamic acid and glutathione-assisted microneedling in the treatment of melasma

Evaluation of Efficacy and Tolerabilty of MelaB3 Serum in Combination of 35% Glycolic Acid Peeling Compared to 35% Glycolic Acid Peeling Alone in Various Hyperpigmentation Conditions

Randomized clinical trial to assess the effectiveness and tolerability of Mela B3 serum in combination with 35% glycolic acid peel vs. 35% glycolic acid peel for the treatment of various hyperpigmentation conditions (melasma, post-inflammatory hyperpigmentation and solar lentigo) and signs of aging in a population of participants from the Autonomous City of Buenos Aires, Argentina.

Expert Consensus on the Clinical Management of Melasma: A Delphi Method Study

This study aims to gather expert opinions on the best ways to treat and manage melasma, a common skin condition characterized by dark patches on the face. Using a method called the Delphi Method, a group of dermatologists and other specialists will participate in several rounds of surveys to share their insights and reach a consensus on the most effective treatments and management strategies. The goal is to create a set of evidence-based guidelines that can help doctors provide more consistent, effective care for patients with melasma. The study will ensure that all experts' opinions are anonymous, and the results will be shared to improve treatment practices worldwide.

Secretome TGF Beta 3

A therapeutic modality currently being developed for melasma is secretome. Secretome is a bioactive molecule secreted by mesenchymal stem cells in a conditioned medium containing a large number of growth factors, cytokines, various macromolecules, and extracellular vesicles, including microvesicles and exosomes, that can stimulate various biological reactions, particularly in modulating new tissue formation. Secretome can provide a depigmenting effect by increasing the proliferation and migration of epidermal keratinocytes, which contain melanin pigment, in line with increased fibroblast synthesis. Secretomes contain various cytokines and growth factors, one of which is transforming growth factor (TGF)-β. TGF-β is primarily secreted by fibroblasts (FB) and, to a lesser extent, by keratinocytes, and plays a crucial role in regulating melanocyte function. TGF-β has been reported to inhibit cAMP/protein kinase A signaling and induce GLI2, which then suppresses microphthalmia-associated transcription factor (MITF), a central transcription factor in melanogenesis. A study by Moon et al. in Korea examined TGF-β3. Moon et al. examined the effects of TGF-β3 on melanogenesis in human melanocytes co-cultured with skin cells irradiated with ultraviolet (UV) light, and in UV-irradiated human skin. The results showed that UVB irradiation or stem cell factor (SCF)/endothelin-1 (ET-1) increased melanogenesis. TGF-β3 effectively inhibited melanin accumulation and tyrosinase activity by downregulating the extracellular signal-regulated kinase (ERK)/microphthalmia-associated transcription factor (MITF) pathway. TGF-β3 increased the expression of keratinocyte differentiation markers. Mechanistically, TGF-β3 inhibits melanogenesis by inhibiting MITF expression, which is regulated by ERK. TGF-β1 reduces MITF but at the risk of inducing skin fibrosis. However, in the study by Moon et al., the aforementioned TGF Beta 1 function was not found in TGF-β3. Furthermore, TGF-β3 restored skin differentiation function in UV-irradiated keratinocytes. To date, there have been no clinical trials comparing intradermal injection of concentrated secretome with intradermal injection of concentrated secretome with the addition of TGF-β3 as a melasma therapy in Indonesia, thus encouraging researchers to conduct further research.

Efficacy and Safety of a Combined Serum Containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES

The goal of this clinical trial is to evaluate the efficacy and safety of a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES when used as a moisturizer after QS-Nd:YAG 1064 nm low-fluence laser treatment for melasma and post-acne hyperpigmentation. The study aims to answer the following main questions: * Does the combination serum reduce hyperpigmented lesions after laser treatment for melasma and post-acne hyperpigmentation? * Does the serum improve skin hydration following laser therapy for melasma? * Is the combination serum safe for use after laser treatment, without causing irritation or adverse effects? Participants will be female patients aged 18-60 years, clinically diagnosed with melasma or post-acne hyperpigmentation (skin types IV and V), who visit the Dermatology \& Venereology Outpatient Clinic for QS-Nd:YAG 1064 low-fluence laser treatment. All participants will have undergone a 2-week priming period using either 2% hydroquinone cream or the test serum prior to laser treatment. Written informed consent is required. Participants will be randomly assigned to receive either the test serum or 2% hydroquinone cream based on a coded allocation. The product will be applied twice daily after facial cleansing, and sunscreen will be used 15 minutes before outdoor activities. Treatment lasts for 2 weeks, with participants recording application times and any adverse effects in a diary. Evaluations-including facial photography, mMASI, mexameter, dermoscopy, Wood's lamp, and PAHPI-will be conducted at baseline and at 1, 2, and 4 weeks post-laser. Erythema and subjective assessment (VAS) will be performed 15 minutes after the laser procedure.