Melasma

21

Review clinical trials related to Melasma. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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.

Participants needed: 152
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Kenvue Brands LLCUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Able to understand and follow study instructions [+5]

Known sensitivity or allergy to cosmetic or skincare products [+7]

Status: Not yet recruiting

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.

Participants needed: 120
Trial details
Age: 18-45Biological sex: AllType: InterventionalSponsor: Combined Military Hospital AbbottabadUpdated: May 28, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

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.

Participants needed: 21
Trial details
Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Kasr El Aini HospitalUpdated: Apr 22, 2026Locations: 1
Eligibility criteria

Clinical diagnosis of bilateral symmetrical facial melasma (epidermal or mixed t... [+6]

Pregnancy or lactation [+5]

Status: Not yet recruiting

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.

Participants needed: 10
Trial details
Age: 18-50Biological sex: FemaleType: InterventionalSponsor: The First Affiliated Hospital of Xinxiang Medical CollegeUpdated: Apr 14, 2026
Eligibility criteria

Patients with contraindications to melatonin, including pregnancy, breastfeeding...

Status: Not yet recruiting

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

Participants needed: 128
Trial details
Phase: Phase 4Age: 18-50Biological sex: AllType: InterventionalSponsor: Hayatabad Medical ComplexUpdated: Apr 13, 2026
Eligibility criteria

Adults age 18 to 50 years Clinically diagnosed Melasma Irrespective of gender an...

pregnant and lactating women Patients with a history of skin allergies to study...

Status: Not yet recruiting

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.

Participants needed: 70
Trial details
Age: 18-50Biological sex: AllType: InterventionalSponsor: Foundation University IslamabadUpdated: Mar 27, 2026Locations: 1
Eligibility criteria

Patients aged 18-50 years [+3]

• Pregnant or lactating women [+4]

Status: Not yet recruiting

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.

Participants needed: 82
Trial details
Age: 35-55Biological sex: FemaleType: InterventionalSponsor: Foundation University IslamabadUpdated: Mar 20, 2026Locations: 1
Eligibility criteria

Female patients aged 35-55 years [+4]

Pregnancy or lactation [+2]

Status: Not yet recruiting

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

Participants needed: 42
Trial details
Phase: Phase 2, Phase 3Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Assiut UniversityUpdated: Mar 4, 2026
Eligibility criteria

• female patients [+2]

pregnancy [+13]

Status: Not yet recruiting

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.

Participants needed: 80
Trial details
Age: 30-70Biological sex: AllType: InterventionalSponsor: Cosmetique Active InternationalUpdated: Feb 24, 2026
Eligibility criteria

Women and men [+9]

Pregnant, breastfeeding or with pregnancy plans. [+18]

Status: Not yet recruiting

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.

Participants needed: 34
Trial details
Age: 30-60Biological sex: FemaleType: InterventionalSponsor: Indonesia UniversityUpdated: Aug 22, 2025Locations: 1
Eligibility criteria

Women diagnosed with melasma. [+4]

Pregnant and breastfeeding women. [+11]

Status: Not yet recruiting

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.

Participants needed: 68
Trial details
Age: 18-60Biological sex: FemaleType: InterventionalSponsor: Dr.dr.Irma Bernadette, SpKK (K)Updated: Aug 13, 2025Locations: 1
Eligibility criteria

Female, aged 18-60 years. [+2]

Pregnant, breastfeeding, or currently taking oral contraceptives at the time of... [+4]

Status: Not yet recruiting

Comparative Efficacy of Resveratrol 1 % Gel and Trichloroacetic Acid 20% in Treatment of Melasma: A Split-face Study

1. To evaluate the efficacy and safety of topical resveratrol 1 % gel in treatment of melasma. 2. To compare between the efficacy of topical resveratrol 1 %gel versrs chemical peeling with TCA 20% in melasma.

Participants needed: 41
Trial details
Age: 18-50Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Jul 11, 2025Locations: 1
Eligibility criteria

• Age: 18-50 years old. [+2]

Pregnancy and lactation. [+5]

Status: Recruiting

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.

Participants needed: 80
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: Fujian Medical University Union HospitalUpdated: Jul 2, 2025Locations: 1
Eligibility criteria

Patients who refuse to sign the informed consent form to participate in the tria... [+12]

Status: Not yet recruiting

Topical Metformin Versus Topical Ketotifen in Melasma Treatment

The study aims to evaluate and compare the efficacy and safety of a new formulation of topical metformin (nanoparticles) versus topical ketotifen (nanoparticles), both alone and combined with micro-needling, for the treatment of melasma. It is a double-blinded, randomized, split-face controlled clinical study involving 102 female patients diagnosed with bilateral melasma.

Participants needed: 60
Trial details
Phase: Phase 2Age: 18-60Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Apr 24, 2025
Eligibility criteria

Female adults of 18 years and above with bilateral melasma . [+2]

Pregnant or nursing women. [+6]

Status: Recruiting

Oral Metformin for Treating Melasma in Latin American Women

The goal of this clinical trial is to learn if metformin can treat melasma in Latin American women. The main question it aims to answer is: \- Can metformin help reduce the dark patches of melasma? Researchers will test two different doses of metformin (500 mg and 1000 mg) to see if either one helps improve melasma. Participants will: * Take a metformin pill every day for three months. * Go to the clinic twice: once at the beginning and once at the end of the study. * Get a phone call from the researchers to check how they're doing and ask about any changes or side effects.

Participants needed: 30
Trial details
Phase: Phase 1, Phase 2Age: 21+Biological sex: FemaleType: InterventionalSponsor: University of Puerto RicoUpdated: Feb 25, 2025Locations: 1
Eligibility criteria

Not listed

Status: Not yet recruiting

Comparison of Effectiveness and Safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in the Treatment of Melasma

This Research is a clinical study with a single-blind randomized controlled trial of evaluators. Clinical trial Randomized Controlled Trial (RCT) design that compares the use of a triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% with a triple cream combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05% in melasma therapy in RSCM-FKUI. This study aims to Assess the effectiveness and safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in melasma patients

Participants needed: 56
Trial details
Age: 30-59Biological sex: FemaleType: InterventionalSponsor: Indonesia UniversityUpdated: Jan 17, 2025Locations: 1
Eligibility criteria

Women [+3]

Plan to be pregnant and breastfeeding women during the study period ( 12 weeks) [+8]

Status: Not yet recruiting

Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis

The purpose of this study was to investigate the efficacy and safety of repairing facial mask containing Asiaticum asiatica in treating disjunctive skin diseases. A multi-center randomized double-blind self-half face control method was used. A computer-generated randomization method was used. Each cheek was randomly assigned to receive the snow glycoside mask and the control group.

Participants needed: 30
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: Nanjing First Hospital, Nanjing Medical UniversityUpdated: Jan 8, 2025Locations: 1
Eligibility criteria

Meet mild to moderate rosacea, acne diagnostic criteria; Meet the diagnostic cri... [+3]

Currently pregnant, planning to become pregnant or breastfeeding; [+6]

Status: Recruiting

Randomized Study Using SM-030 Gel for Adults With Melasma

Brief Summary This is a phase 2b, observer-blinded, randomized study that will evaluate the safety and efficacy of topically applied SM-030 gel 0.64% and SM-030 gel 0.08% compared against placebo gel in healthy adult male and female subjects with Melasma. The study will be comprised of a 12-week twice daily dosing period and a 4-week additional safety follow-up period. Approximately 138 subjects who meet the eligibility criteria, notably with a clinical diagnosis of Melasma will be randomized in a 3:2:1 ratio to one of three treatment arms: SM-030 gel 0.64% (N=69), Placebo gel (N=46), or SM-030 gel 0.08% (N=23). Subjects will be competitively enrolled in Mexico and El Salvador across 5 sites (4 sites in Mexico and 1 in El Salvador). Subjects will be assessed for safety and efficacy at each visit.

Participants needed: 138
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: DermBiont, Inc.Updated: Dec 13, 2024Locations: 2
Eligibility criteria

Male or Female age 18-65 with Fitzpatrick skin type II through V and a clinical...

Positive urine pregnancy test, pregnant, lactating, or female of childbearing po... [+6]

Status: Recruiting

The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis

The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to expert based clinical severity grading.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Integrative Skin Science and ResearchUpdated: Aug 27, 2024Locations: 1
Eligibility criteria

Adults with acne, rosacea, melasma or seborrheic dermatitis

Prisoners [+2]

Status: Not yet recruiting

Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma

This 6 month, comparative study assesses the benefit of a dermocosmetic regimen (Serum B3 + B3 retinol night cream) for 6 months compared to hydroquinone 4% (the gold standard in hyperpigmentation) followed by the dermocosmetic regimen for 3 months or the Kligman Trio for 3 months followed by the dermocosmetic regimen for 3 months in adult women with melasma on the face.

Participants needed: 150
Trial details
Age: 18-65Biological sex: FemaleType: InterventionalSponsor: Cosmetique Active InternationalUpdated: Jul 23, 2024Locations: 1
Eligibility criteria

18-65 years [+3]

Subjects under topical or systemic retinoids; [+12]

Status: Recruiting

Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy

This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in RSCM-FKUI This study aims to Assess the effectiveness and safety of intradermal concentrated secretome injection therapy, triple combination cream, and intradermal tranexamic acid injection in melasma patients, determine the quality of life profile of melasma patients after triple combination cream therapy in melasma therapy, and determine SOD levels in melasma patients. This research will be attended by 90 research subjects

Participants needed: 90
Trial details
Age: 30-60Biological sex: FemaleType: InterventionalSponsor: Dr.dr.Irma Bernadette, SpKK (K)Updated: Jul 24, 2024Locations: 2
Eligibility criteria

Women diagnosed with melasma. [+4]

Pregnant and breastfeeding women. [+11]