An interventional study of Isobutylamido-thiazolyl-resorcinol Cream 0.2% and Vehicle in Facial Hyperpigmentation, sponsored by Institute of Dermatology, Thailand. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Institute of Dermatology, Thailand · Not applicable, Interventional, and Other
Facial hyperpigmentation is a common skin issue that can cause embarrassment and affect the quality of life in majority of people. The investigators are conducting a research to study an efficacy and tolerability of Isobutylamido-thiazolyl-resorcinol 0.2% in lightening of the facial hyperpigmentation in comparison to vehicle intervention in 4, 8 and 12-week period. The ultimate goal is to provide the best cosmetic cream to improve the quality of life of people who suffer from facial hyperpigmentation.
Facial hyperpigmentation is a skin issue that occurs frequently in people with darker skin types. Studies show that the prevalence of facial hyperpigmentation is related to ethnicity and is accounted for up to 40%of the total population. The pathogenesis of facial hyperpigmentation is still unclear, but several factors seem to contribute such as ultraviolet radiation, female hormones, and genetics, which increase melanin production in the skin cells, specifically the epidermal melanocyte, and dermal melanophage. Hyperpigmentation can be embarrassing and affect the quality of life in the pertained individuals.
Tyrosinase enzyme plays a key element in melanin production which causes dark areas. In 2018, several studies have reported a new cosmetic product using Isobutylamido-thiazolyl-resorcinol (Beiersdorf AG, Hamburg, Germany) in facial hyperpigmentation. In vitro studies found that in melanocyte culture, Isobutylamido-thiazolyl-resorcinol inhibit melanin production. Studies discovered that Isobutylamido-thiazolyl-resorcinol 0.2% can reduce facial hyperpigmentation within 4 weeks. Hyperpigmentation begin to fade away within 12 weeks of daily application.
The objective is to study efficacy and tolerability of a cosmetic formulation with Isobutylamido-thiazolyl-resorcinol 0.2% compared to its vehicle in facial hyperpigmentation after 4, 8 and 12-week.
This is a randomized double-blind and vehicle-controlled study. Two hundred subjects both male and female 18 years or older with facial hyperpigmentation are recruited in the study. The study was performed at the Institute of Dermatology, Bangkok, Thailand. Subjects agree to attend monthly sessions every 4 weeks for 12 weeks.
Institute of Dermatology, Thailand is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
The cream contains 0.2% Isobutylamido-thiazolyl-resorcinol.
Other: Isobutylamido-thiazolyl-resorcinol Cream 0.2%
The cream contains no active ingredients.
Other: Vehicle
Each bottle contains Isobutylamido-thiazolyl-resorcinol cream 0.2% to be applied on the entire face twice daily for 12 weeks.
Each bottle contains vehicle cream to be applied on the entire face twice daily for 12 weeks.
Color assessment of facial hyperpigmentation by Color Analysis program will be evaluated every visit.
Each visit, photos are taken on all patients by VISIA-CR system camera on 3 positions of the face, straight and 37\* on both sides with standard unfiltered and cross polarized lens. Each time the photos are filed and the colors are analyzed in order to be compared the changes between visits.
Time frame: 12 weeks
Physician's Global Assessment of facial hyperpigmentation will be evaluated every visit.
Evaluate the changes of facial hyperpigmentation by global assessment score: 0=Completely clear,1=Almost clear, 2=Marked improved, 3=Moderate improved, 4=Slight improved, 5=No change, 6=Worse
Time frame: 12 weeks
Patient's Global Assessment of facial hyperpigmentation will be evaluated every visit.
Evaluate the changes of facial hyperpigmentation by global assessment score: 0=Completely clear,1=Almost clear, 2=Marked improved, 3=Moderate improved, 4=Slight improved, 5=No change, 6=Worse
Time frame: 12 weeks
Patient's Self-Grading of facial hyperpigmentation will be evaluated every visit.
Visual self-grading by patients from 1 to 10 by 1 is the least and 10 is the most in the criteria of evenness, spots and skin clarity
Time frame: 12 weeks
Evaluate side effects of Isobutylamido-thiazolyl-resorcinol cream 0.2% or vehicle cream every visit.
All patients are asked about the side effects of using the cream such as eczema, hypopigmentation, and redness.
Time frame: 12 weeks
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Institute of Dermatology, Thailand