Efficacy, Safety, and Satisfaction of Kligman’s Formula With and Without Melatonin in Melasma Treatment: A Randomized, Double-Blind, Split-Face Comparative Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191003044970N1

Enrollment

Registered

2025-07-18

Start date

2025-08-06

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

hyperpigmentation skin disorders. Other disorders of diminished melanin formation

Interventions

Intervention 1: Intervention group: Drug A (Kligman’s formula with melatonin): A topical cream containing 3% hydroquinone, 0.5% hydrocortisone, 0.0125% tretinoin, 4% propylene glycol, 0.5% melatonin,

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Suffering from hyperpigmentation disorder diagnosed by a dermatologist Over 18 years of age Patients who are not being treated with any other treatment method at the time of entering the study and receiving any other topical medication

Exclusion criteria

Exclusion criteria: Having other diseases and skin cancer Pregnant and lactating women (breast-feeding) Having Koebnerization phenomenon and keloidal tendency Involving more than 30% of the body surface Use of drugs that weaken the immune system or cytotoxic drugs in the last year Radiation therapy (UV therapy) in the last 6 months. Bleeding diathesis Having disease Active infection

Design outcomes

Primary

Measure	Time frame
Skin lightening. Timepoint: At the beginning of the study (before the start of the intervention), 4, 8 and 12 weeks after the start of the treatment and 1 month after the end of the treatment. Method of measurement: Skin pigmentation intensity is measured using the MODIFIED MASI SCORE: Melasma Area and Severity Index. Also, at each visit, a skin analyzer is used to evaluate biometric features including a colorimeter, Visioface 1000D, Tewameter, Cutometer, Mexameter, and Sebumeter, and an ultrasound skin imaging system to assess transepidermal water loss (TEWL), skin pores, color, melanin content, erythema, fat content, and thickness and density of the epidermis and dermis. Patient satisfaction is also measured by the physician and the patient with a visual analog scale (VAS).	—

Measure

Time frame

Skin lightening. Timepoint: At the beginning of the study (before the start of the intervention), 4, 8 and 12 weeks after the start of the treatment and 1 month after the end of the treatment. Method of measurement: Skin pigmentation intensity is measured using the MODIFIED MASI SCORE: Melasma Area and Severity Index. Also, at each visit, a skin analyzer is used to evaluate biometric features including a colorimeter, Visioface 1000D, Tewameter, Cutometer, Mexameter, and Sebumeter, and an ultrasound skin imaging system to assess transepidermal water loss (TEWL), skin pores, color, melanin content, erythema, fat content, and thickness and density of the epidermis and dermis. Patient satisfaction is also measured by the physician and the patient with a visual analog scale (VAS).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Mehrzadi

Iran University of Medical Sciences

sa-mehrzadi@yahoo.com+98 21 8670 3134

Outcome results

None listed

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