Health Condition 1: L810- Postinflammatory hyperpigmentation
Conditions
Interventions
Intervention1: Demelan Nexa Serum: Applied topically twice daily for 12 weeks
Control Intervention1: NIL: NIL
Sponsors
Eris Lifesciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female patients aged 18 to 60 years. 2.Patients with a clinical diagnosis of melasma, confirmed by a qualified dermatologist. 3.Patients with stable melasma for at least 3 months prior to enrollment. 4.Agreement to use sun protection measures, including sunscreen, throughout the study duration. 5.Ability and willingness to comply with study procedures, including clinical assessments, photography, and follow-up visits. 6.Patients who provide written informed consent prior to participation.
Exclusion criteria
Exclusion criteria: 1.Patients with skin conditions other than melasma on the face thatmmay interfere with clinical assessment (e.g., active acne, eczema, psoriasis, dermatitis, infections). 2.Patients with post-inflammatory hyperpigmentation or other pigmentary disorders not consistent with melasma. 3.Use of topical depigmenting agents (e.g., hydroquinone, retinoids, corticosteroids, tranexamic acid, chemical peels) on the face within 4 Weeks prior to enrollment. 4.Use of systemic treatments known to affect pigmentation (e.g., oral tranexamic acid, hormonal therapy, isotretinoin) within 3 months prior to enrollment. 5.Known hypersensitivity or allergy to any ingredient of the study product (tranexamic acid, glycolic acid, niacinamide, hyaluronic acid, or formulation excipients). 6.Pregnant or lactating women, or women planning pregnancy during the study period. Pregnancy status will be determined based on participant self-report and clinical assessment by the investigator. Pregnancy testing will not be routinely performed. 7.Participation in another clinical or cosmetic study within 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in mMASI scoreTimepoint: Baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Melanin Index (MI), Erythema Index (EI), skin hydration, and Transepidermal Water Loss (TEWL) from baseline to Weeks 2, 4, 8, 12, and 16 will be assessed. Clinical improvement in pigmentation, Patient Global Assessment (PGA), patient satisfaction, and safety/tolerability including adverse events and local skin reactions will also be evaluated throughout the study period up to Week 16Timepoint: baseline to Weeks 2, 4, 8, 12, and 16 | — |
Countries
India
Contacts
Public ContactDr B S Chandrashekar
CUTIS Academy of Cutaneous Sciences
Outcome results
None listed