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To study the role of oxygen byproducts in the blood in the causation of facial pigmentation or melasma

Role of melatonin and oxidative stress in melasma and correlation with melasma area and severity index

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/05/013910
Enrollment
150
Registered
2018-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Melasma or dark pigmentation on face

Interventions

Intervention1: Cases of melasma: Cases of melasma and controls will be selected according to the criteria described above. Following an informed consent, cases will be examined clinically to confirm t

Sponsors

Indian Association of Dermatologists Venereolologists and LeprologistsIADVLLoreal Research Grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for cases 1. Age more than 18 years. â?¨ 2. Patients with bilateral, symmetrical light brown to dark, muddy brown macules and patcheson face with irregular, serrated and geographical borders, and diagnosed clinically as melasma. 3. Have not received treatment in the past 3 month. â?¨ Inclusion criteria for controls 1. Age more than 18 years. â?¨ 2. Age and sex matched controls not having melasma

Exclusion criteria

Exclusion criteria: Exclusion criteria for cases 1. History of hypertension, diabetes mellitus, tuberculosis or any chronic renal or hepatic diseases. 2. Immunocompromised patients. â?¨ 3. Chronic cigarette smoking or alcohol intake. â?¨ 4. History of ingestion of oral contraceptives, folic acid, glutathione, vitamins E or C, selenium, zinc or iron, antidepressants in the last three months. 5. Patients who work in shift duties, have undertaken international travel in last 4 weeks or suffer from sleep disturbances or neuropsychiatric disorders Exclusion criteria for controls 1. History of hypertension, diabetes mellitus, tuberculosis or any chronic renal or hepatic diseases. 2. Immunocompromised patients. 3. Chronic cigarette smoking or alcohol intake. 4. History of ingestion of oral contraceptives, folic acid, glutathione, vitamins E or C, â?¨selenium, zinc or iron, antidepressants in the last three months. 5. Those suffering from alopecia areata/seborrheic dermatitis/vitiligo/ acne/ rosacea/ skincancer/psoriasis/asthma. 6. Patients who work in shift duties, have undertaken international travel in last 4 weeks or suffer from sleep disturbances or neuropsychiatric disorders

Design outcomes

Primary

MeasureTime frame
Oxidative stress has been proposed as one of the most important triggering event in the etiopathogenesis of melasma. However there are very few studies that evaluate its role in melasma.There is no study evaluating role of melatonin in melasma although topical and oral melatonin is available as treatment in a single study.The primary outcome of this study will be to assess the role of melatonin and serum markers of oxidative stress in melasma.Timepoint: Nine months

Secondary

MeasureTime frame
The obtained values of tests in melasma group will be compared with those of control group, and correlated with Modified Melasma Area Severity Index.Timepoint: Nine months

Countries

India

Contacts

Public ContactRashmi Sarkar

Department of Dermatology Maulana Azad Medical College and Lok Nayak Hospital New Delhi-110002

rashmisarkar@gmail.com9818244349

Outcome results

None listed

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