Efficacy and Tolerability of an Isobutylamido-thiazolyl-resorcinol Cream 0.2% for Facial Hyperpigmentation

NCT ID: NCT03926845

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2021-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Facial Hyperpigmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Isobutylamido-thiazolyl-resorcinol Cream 0.2%

The cream contains 0.2% Isobutylamido-thiazolyl-resorcinol.

Group Type: ACTIVE_COMPARATOR

Isobutylamido-thiazolyl-resorcinol Cream 0.2%

Intervention Type: OTHER

Each bottle contains Isobutylamido-thiazolyl-resorcinol cream 0.2% to be applied on the entire face twice daily for 12 weeks.

Vehicle

The cream contains no active ingredients.

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: OTHER

Each bottle contains vehicle cream to be applied on the entire face twice daily for 12 weeks.

Interventions

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.

Intervention Type: OTHER

Vehicle

Each bottle contains vehicle cream to be applied on the entire face twice daily for 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subjects are Thai adults age 18 years old and above .

2. Subjects suffer from facial hyperpigmentation for at least 10 years, with or without freckles, lentigo or dark sports.

3. Subjects must be able to attend monthly sessions in the period of 12 weeks session.

4. Subjects must refrain from using other whitening cream such as hydroquinone, azelaic acid, kojic acid, arbutin, glycolic acid or any other creams which whiten the skin including chemical peel or whitening pills such as Tranexamic acid at least 1 month before the trial.

5. Subjects must refrain from receiving both ablative and nonablative laser treatment at least 3 months before the trial.

6. Subjects who can apply sun screen with UVA and UVB protection that has a minimum of SPF30 daily.

Exclusion Criteria

1. Subjects who have conditions such as Lichen planus pigmentosus, Pigmented contact dermatitis, Photosensitivity, Ashy dermatosis, Dermal melanosis, e.g. Nevus of Hori, Nevus of Ota, Dermal melanocyte hamartoma

2. Subjects with a congenital disease which darkens skin tone, e.g. Addison's disease, Cushing's syndrome and Thyrotoxicosis

3. Subjects with a congenital or serious disease with unpredictable symptoms such as Cirrhosis, cardiovascular diseases, Neurological diseases, gastrointestinal disease, Reproductive system diseases, Cancer and Psychiatric diseases.

4. Subjects who take pills that might cause hyperpigmentation such as chemotherapy, Amiodarone, Chlorpromazine, Hydroxychloroquine, Gold, Birth control pills (if related to causing hyperpigmentation issue)

5. Female subjects with pregnancy and breastfeeding.

6. Subjects who are allergic to chemical compound in the cream such as Alcohol denat, Phenoxyethanol or fragrance.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beiersdorf (Thailand) Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Institute of Dermatology, Thailand

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chinmanat Lekhavat

Assistant Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chinmanat Lekhavat, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Dermatology

Locations

Institute of Dermatology

Ratchathewi, Bangkok, Thailand

Countries

Thailand

References

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Reference Type: BACKGROUND

PMID: 12622786 (View on PubMed)

Rossi AM, Perez MI. Treatment of hyperpigmentation. Facial Plast Surg Clin North Am. 2011 May;19(2):313-24. doi: 10.1016/j.fsc.2011.05.010.

Reference Type: BACKGROUND

PMID: 21763992 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 16631967 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 15117368 (View on PubMed)

Espin JC, Varon R, Fenoll LG, Gilabert MA, Garcia-Ruiz PA, Tudela J, Garcia-Canovas F. Kinetic characterization of the substrate specificity and mechanism of mushroom tyrosinase. Eur J Biochem. 2000 Mar;267(5):1270-9. doi: 10.1046/j.1432-1327.2000.01013.x.

Reference Type: BACKGROUND

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Weatherall IL, Coombs BD. Skin color measurements in terms of CIELAB color space values. J Invest Dermatol. 1992 Oct;99(4):468-73. doi: 10.1111/1523-1747.ep12616156.

Reference Type: BACKGROUND

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Other Identifiers

013/2562

Identifier Type: -

Identifier Source: org_study_id