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A New Skin Peel Treatment Combining Tranexamic Acid, Glycolic Acid, and Vitamin C to Improve Melasma

A Novel Triple Combination (Tranexamic Acid, Glycolic Acid, and Vitamin C) Chemical Peel for Melasma - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078352
Enrollment
50
Registered
2024-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L814- Other melanin hyperpigmentation

Interventions

Intervention1: Novel Triple Combination Chemical Peel (Containing Tranexamic Acid, Glycolic Acid, and Vitamin C): Active Ingredients: Tranexamic Acid: 10% (anti-melanogenic, reduces pigmentation). Gly

Sponsors

B Sai Rithika Reddy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years and older, 2. Clinical diagnosis of melasma based on characteristic hyperpigmented patches on the face, 3. Patients who have not received any medical treatment for melasma

Exclusion criteria

Exclusion criteria: 1.Patients not willing to be a part of the study 2.Patients less than 18 years of age 3.Pregnancy 4.lactation. 5.History of hypersensitivity or allergic reactions to any ingredients in the chemical peel formulation. 6.Active dermatological conditions affecting facial skin. 7.Patients with unrealistic expectations 8.Patients not consenting for therapy

Design outcomes

Primary

MeasureTime frame
Efficacy of the Combination Chemical Peel: Measured by a reduction in melasma severity using the Melasma Area and Severity Index (MASI) score. MASI score will be recorded at baseline, during treatment, and post-treatment to evaluate the degree of improvement in hyperpigmented patches. Improvement in Patient Quality of Life: Assessed through a validated questionnaire, such as the Melasma Quality of Life Scale (MELASQOL), which captures the psychological and social impact of melasma. Patient Satisfaction: Subjective improvement noted by patients using standardized tools, such as a patient satisfaction survey or Global Aesthetic Improvement Scale (GAIS).Timepoint: 8 weeks

Secondary

MeasureTime frame
1.Safety Profile: Incidence of adverse effects such as: Persistent erythema. Post-inflammatory hyperpigmentation. Post-inflammatory hypopigmentation. Allergic reactions. 2.Improvement in Quality of Life: Measured through MELASQOL, reflecting the psychological and social impact of melasma improvement on patients. 3.Comparative Analysis: Comparison of the efficacy and safety profile between the novel combination chemical peel and the standard treatment group.Timepoint: Evaluations will be conducted at baseline, during interim visits, at the end of the treatment (Week 8), and during a follow-up visit (Week 12).

Countries

India

Contacts

Public ContactB Sai Rithika Reddy

Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences

drsharadagovardhan@gmail.com9972219160

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026