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Efficacy and safety of 0.15% Thiamidol combination with hyaluronic acid versus 0.15%Thiamidol or hyaluronic acid alone in treatment of melasma : A randomized single-blind trial

Efficacy and safety of 0.15% Thiamidol combination with hyaluronic acid versus 0.15%Thiamidol or hyaluronic acid alone in treatment of melasma : A randomized single-blind trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200710001
Enrollment
96
Registered
2020-07-10
Start date
2019-09-02
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Melasma is acquired light to dark&#45

Interventions

combination of &#45
0.15%thiamidol : tyrosinase inhibitor and &#45
hyaluronic acid ,0.15%thiamidol : tyrosinase inhibitor,humectant
combination 0.15%thiamidol and hyaluronic acid,0.15%thiamidol,hyaluronic acid

Sponsors

Faculty of medicine, Thammasat university
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Women 18-65 years of age having general good health 2.Fitzpatrick skin type II-IV 3.Individuals with any types of melasma 4.Individuals who use sunscreen daily with at least SPF30 5.Individuals that willing to provide written informed consent and are able to read, speak, write, and understand Thai. 6.Individuals of child-bearing potential who are willing to take a urine pregnancy test prior to study enrollment and when deemed appropriate by the investigator and/or sponsor 7. Individuals of child-bearing potential who use an acceptable method of contraception throughout the study and must be on a stable use for 3 months prior to study enrollment and must not alter their use, including dose or regimen for the duration of the study 8. Willing to withhold all facial treatments during the course of the study, including botulinum toxin, injectable fillers, microdermabrasions, intense pulse light, peels, laser treatment and thread 9. Willing to co-operate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately

Exclusion criteria

Exclusion criteria: 1. History of laser resurfacing procedures, deep skin peel, botulinum toxin, or injection with a dermal filler, or cosmetic procedures on the face within 6 months prior to enrollment. 2. Use of depigmenting products within 2 months prior to enrollment. 3. Use of any topical medications on the face for the treatment of hyperpigmented lesions or other conditions, or use of photosensitizing medication or procedures, bleaching products on the face, UV light therapy, topical prescription treatments, transamin, glutathione, vitamin or topical tretinoin on the face, or Use of acitretin, isotretinoin, systemic retinoids, methotrexate, or photoallergic, phototoxic, or photo-sensitizing drugs fewer than 30 days prior to the study entry. 4. Facial microdermabrasion treatment within 6 weeks prior to study entry. 5. Known allergies to facial skin care products. 6. Pregnancy or nursing or planning to become pregnant during the study according to subject self-report, including those who are not using an acceptable method of contraception throughout the study. 7. History of skin cancer. 8. A health condition and/or pre-existing or dormant dermatologic disease on the face (e.g., psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriations) that the investigator deems inappropriate for participation or could interfere with the outcome of the study. 9. History of immunosuppression/immune deficiency disorders, including HIV infection or acquired immunedeficiency syndrome, or currently using immunosup- pressive medications and/or radiation as determined by study documentation. 10. Uncontrolled disease such as asthma, diabetes, hyper- tension, hyperthyroidism, or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet or medication.

Design outcomes

Primary

MeasureTime frame
melanin average level 0,2,4,8,12 weeks antera

Secondary

MeasureTime frame
modified MASI score and TEWL 0,2,4,8,12 wk by investigator and tewameter

Countries

Thailand

Contacts

Public ContactWareeporn Disphanurat

Faculty of medicine, Thammasat university

dwareeporn@gmail.com081-6582941

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026