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Evaluation of a new substance (isobutylamido thiazolyl resorcinolcream) compared to the use of hydroquinone 4% cream to treat facial blemishes

Efficacy and safety of topical 0,2% Thiamidol versus 4% Hydroquinone in the treatment of facial Melasma in women: a randomized and evaluator blinded clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-87kphy
Enrollment
Unknown
Registered
2020-10-09
Start date
2020-10-13
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Melasma

Interventions

Intervention Group: 25 participants (women with facial melasma)
application of 0.2% isobutylamido thiazolyl resorcinol cream 5% cream on the melasma spots (topically) in two layers in the morning and two layers in the morning. During the day, colored facial sunscr
application of 4% hydroquinone in cream (topically) on the stains at night. During the day: application of colored facial sunscreen (guidance for reapplication every 3 hours) tinted facial sunscreen

Sponsors

Faculdade de Medicina de Botucatu (FMB - Unesp)
Lead Sponsor
Escola Paulista de Medicina (EPM/UNIFESP)
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Women with facial melasma 18 to 50 years old, Fitzpatrick's phototypes II to V.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women; women with vitiligo or photosensitizing diseases; individuals who are using other whitening substances and those who refuse to be photographed; photoexposed women and menopausal women (after 50 years).

Design outcomes

Primary

MeasureTime frame
Evaluation of the severity of melasma assessed using the mMASI score (modified Melasma Area and Severity Index); evaluation at T30 (30th day) and T90 (90th day of treatment); a percentage reduction of at least 10% is expected in T90 compared to T0.

Secondary

MeasureTime frame
Secondary outcomes will be evaluated through MELASQoL, dermatoscopy and clinical evaluation by the participant and the researcher, both at T0 and T60 and T90.

Countries

Brazil

Contacts

Public ContactHelio Miot
heliomiot@gmail.com+55 14 38134727

Outcome results

None listed

Source: REBEC (via WHO ICTRP)