Combination of Hydroquinone and Fractional CO2 Laser vs. Hydroquinone Monotherapy in Melasma Treatment: A Randomized Split-face Clinical Trial

Comparison of Effectiveness of Hydroquinone 4% and Fractional CO2 Laser combination vs. Hydroquinone 4% Monotherapy in women from the age range of 20-50 years with melasma.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20171222037987N1

Enrollment

Registered

2018-06-30

Start date

2015-02-04

Completion date

Unknown

Last updated

2018-07-16

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

Conditions

melasma. Chloasma

Interventions

Intervention 1: Intervention group: for each patient one side of the face was randomly allotted to topical hydroquinone 4% and Fractional CO2 laser (combination therapy group). Patients received thre

Eligibility

Sex/Gender

Female

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Female patients Age range of 20-50 years Fitzpatrick skin types II-V Bilateral melasma on cheeks

Exclusion criteria

Exclusion criteria: History of receiving laser therapy and topical therapeutic agents in the previous three months History of receiving Isotretinoin in the past six months History of receiving OCP, other bleaching creams, phenytoin, phototoxic and photoallergic drugs Pregnancy Lactating

Design outcomes

Primary

Measure	Time frame
Severity of the melasma lesions was assessed objectively based on Darkness (D) and Homogeneity (H) using a 7-point scale (0-6). Timepoint: The darkness and homogeneity scores were obtained in the first visit and the 3 laser sessions at three-week intervals and the follow-up sessions at 1 and 3 months after the last laser session. Method of measurement: darkness and homogeneity : 7-point scale(compare with the sample) patient's satisfaction with the treatment :visual analogue scale (VAS) by scoring between 0 and 10 response to treatment : physician global assessment.	—

Measure

Time frame

Severity of the melasma lesions was assessed objectively based on Darkness (D) and Homogeneity (H) using a 7-point scale (0-6). Timepoint: The darkness and homogeneity scores were obtained in the first visit and the 3 laser sessions at three-week intervals and the follow-up sessions at 1 and 3 months after the last laser session. Method of measurement: darkness and homogeneity : 7-point scale(compare with the sample) patient's satisfaction with the treatment :visual analogue scale (VAS) by scoring between 0 and 10 response to treatment : physician global assessment.

—

Secondary

Measure	Time frame
Patient's satisfaction with the treatment. Timepoint: 3 months after the last laser session. Method of measurement: visual analogue scale (VAS) by scoring between 0 and 10.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarahnaz Fatemi Naeini

Esfahan University of Medical Sciences

fatemi@med.mui.ac.ir+98 31 3620 2087

Outcome results

None listed

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