Efficacy and Tolerability of an Isobutylamido-thiazolyl-resorcinol Cream 0.2% for Facial Hyperpigmentation
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|ClinicalTrials.gov Identifier: NCT03926845|
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Facial Hyperpigmentation||Other: Isobutylamido-thiazolyl-resorcinol Cream 0.2% Other: Vehicle||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a randomized, vehicle controlled, double-blind study and is performed at the Institute of Dermatology. Subjects are randomized into 2 groups by a computer prior to the start of the study - group 1 receives Isobutylamido-thiazolyl-resorcinol 0.2% cream and group 2 receives vehicle cream for 12 weeks. Both Study products have to be applied twice daily.Total of 4 clinical sessions are carried out in order to evaluate Isobutylamido-thiazolyl-resorcinol 0.2% efficacy and tolerability at week 4, 8 and 12. Subjects and investigators are blinded about allocation. The appearance of the vehicle formulation was similar to the verum formulation and could not be distinguished neither by patients nor by the investigator.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Tolerability of an Isobutylamido-thiazolyl-resorcinol Cream 0.2% for Facial Hyperpigmentation, A Randomized Double-blind and Vehicle-Controlled Study|
|Actual Study Start Date :||April 29, 2019|
|Estimated Primary Completion Date :||October 29, 2019|
|Estimated Study Completion Date :||October 29, 2019|
Active Comparator: Isobutylamido-thiazolyl-resorcinol Cream 0.2%
The cream contains 0.2% Isobutylamido-thiazolyl-resorcinol.
Other: Isobutylamido-thiazolyl-resorcinol Cream 0.2%
Each bottle contains Isobutylamido-thiazolyl-resorcinol cream 0.2% to be applied on the entire face twice daily for 12 weeks.
Placebo Comparator: Vehicle
The cream contains no active ingredients.
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. [ Time Frame: 12 weeks ]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.
- Physician's Global Assessment of facial hyperpigmentation will be evaluated every visit. [ Time Frame: 12 weeks ]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
- Patient's Global Assessment of facial hyperpigmentation will be evaluated every visit. [ Time Frame: 12 weeks ]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
- Patient's Self-Grading of facial hyperpigmentation will be evaluated every visit. [ Time Frame: 12 weeks ]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
- Evaluate side effects of Isobutylamido-thiazolyl-resorcinol cream 0.2% or vehicle cream every visit. [ Time Frame: 12 weeks ]All patients are asked about the side effects of using the cream such as eczema, hypopigmentation, and redness.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926845
|Contact: Chinmanat Tangjaturonrusamee, MDfirstname.lastname@example.org|
|Contact: Jinda Rojanamatin, MDemail@example.com|
|Institute of Dermatology||Recruiting|
|Ratchathewi, Bangkok, Thailand, 10400|
|Contact: Chinmanat Tangjaturonrusamee, M.D.|
|Principal Investigator:||Chinmanat Tangjaturonrusamee, MD||Institute of Dermatology|