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Studying the effect and efficacy of carboxytherapy on melasma compared to tranexamic acid

Comparison of efficacy of carboxytherapy and intralesional injection of tranexamic acid in treatment of melasma:Double-sided, non-blinded clinical study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250309065002N1
Enrollment
28
Registered
2025-04-07
Start date
2025-04-21
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

Melasma. Chloasma

Interventions

Intervention 1: Control group:
and in addition, if the needle becomes dull, we replace it with a new needle. The patient

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Presence of melasma lesions symmetrically on both sides of the face Both genders

Exclusion criteria

Exclusion criteria: Active skin infections in the area where carboxytherapy or tranexamic acid injections is performed Having any systemic disease such as diabetes, kidney disease, heart disease, respiratory disease, liver disease, severe anemia, etc History of diseases with hormonal disorders such as thyroid problems, polycystic ovary, metabolic syndrome, etc Having connective tissue diseases or genodermatoses Drug therapy (also including dietary supplements) from 6 weeks before the start of the study History of any treatment for melasma within 6 weeks prior to the start of the study Smoking, alcohol, and drug abuse Pregnancy Breastfeeding Vascular diseases and accidents such as embolism and vascular thrombosis

Design outcomes

Primary

MeasureTime frame
Severity of Melasma. Timepoint: It is evaluated from the first session, before each session, and 6 weeks after the last session. Method of measurement: Through clinical examination and digital photography and matching the findings with the pigmentation scoring system (0 score : no visible pigmentation _1 score : barely visible pigmentation _2 score : mild pigmentation _3 score : high pigmentation _4 score : severe pigmentation) and Finally, the inclusion in the Melasma Area Severity Index scoring formula (MASI Score).;The extent of melasma. Timepoint: It is evaluated from the first session, before each session, and 6 weeks after the last session. Method of measurement: Through clinical examination and digital photography and matching the findings with the extent of involvement scoring system (0 points: no involvement _1 point: involvement less than 10% _2 points: involvement between 10 and 29% _3 points: involvement between 30 and 49% _4 points: involvement between 50 and 69% _5 points: involvement between 70 and 89% _6 points: involvement between 90 and 100%) and finally placing in the melasma extent and severity scoring formula.;Quality of life in melasma. Timepoint: It is assessed from the first session, before each session, and 6 weeks after the last session and is noted in the questionnaire. Method of measurement: Through a subjective assessment system that emphasizes more on the emotional and psychological aspects of melasma, called the Melasma Quality of Life Scale (MelasQoL) Questionnaire. Based on a score of 0 (not bothersome at all) to 7 (troublesome all the time), patients rate their feelings on the following: ( )Appearance of skin condition

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Amiri Hazaveh

Arak University of Medical Sciences

mohamad11.amiri@gmail.com+98 86 3457 3187

Outcome results

None listed

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