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

Primary Purpose

Facial Hyperpigmentation

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Isobutylamido-thiazolyl-resorcinol Cream 0.2%

Vehicle

About this trial

This is an interventional other trial for Facial Hyperpigmentation focused on measuring Isobutylamido-thiazolyl-resorcinol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects are Thai adults age 18 years old and above .
Subjects suffer from facial hyperpigmentation for at least 10 years, with or without freckles, lentigo or dark sports.
Subjects must be able to attend monthly sessions in the period of 12 weeks session.
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.
Subjects must refrain from receiving both ablative and nonablative laser treatment at least 3 months before the trial.
Subjects who can apply sun screen with UVA and UVB protection that has a minimum of SPF30 daily.

Exclusion Criteria:

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
Subjects with a congenital disease which darkens skin tone, e.g. Addison's disease, Cushing's syndrome and Thyrotoxicosis
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.
Subjects who take pills that might cause hyperpigmentation such as chemotherapy, Amiodarone, Chlorpromazine, Hydroxychloroquine, Gold, Birth control pills (if related to causing hyperpigmentation issue)
Female subjects with pregnancy and breastfeeding.
Subjects who are allergic to chemical compound in the cream such as Alcohol denat, Phenoxyethanol or fragrance.

Sites / Locations

Institute of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Isobutylamido-thiazolyl-resorcinol Cream 0.2%

Vehicle

Arm Description

The cream contains 0.2% Isobutylamido-thiazolyl-resorcinol.

The cream contains no active ingredients.

Outcomes

Primary Outcome Measures

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.

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

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03926845

First Posted

April 22, 2019

Last Updated

March 28, 2022

Sponsor

Institute of Dermatology, Thailand

Collaborators

Beiersdorf (Thailand) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03926845

Brief Title

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

Official Title

Efficacy and Tolerability of an Isobutylamido-thiazolyl-resorcinol Cream 0.2% for Facial Hyperpigmentation, A Randomized Double-blind and Vehicle-Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

April 29, 2019 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institute of Dermatology, Thailand

Collaborators

Beiersdorf (Thailand) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facial Hyperpigmentation

Keywords

Isobutylamido-thiazolyl-resorcinol

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Isobutylamido-thiazolyl-resorcinol Cream 0.2%

Arm Type

Active Comparator

Arm Description

The cream contains 0.2% Isobutylamido-thiazolyl-resorcinol.

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

The cream contains no active ingredients.

Intervention Type

Other

Intervention Name(s)

Isobutylamido-thiazolyl-resorcinol Cream 0.2%

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Vehicle

Intervention Description

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

Primary Outcome Measure Information:

Title

Color assessment of facial hyperpigmentation by Color Analysis program will be evaluated every visit.

Description

Time Frame

12 weeks

Title

Physician's Global Assessment of facial hyperpigmentation will be evaluated every visit.

Description

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

Title

Patient's Global Assessment of facial hyperpigmentation will be evaluated every visit.

Description

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

Title

Patient's Self-Grading of facial hyperpigmentation will be evaluated every visit.

Description

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

Title

Evaluate side effects of Isobutylamido-thiazolyl-resorcinol cream 0.2% or vehicle cream every visit.

Description

All patients are asked about the side effects of using the cream such as eczema, hypopigmentation, and redness.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects are Thai adults age 18 years old and above . Subjects suffer from facial hyperpigmentation for at least 10 years, with or without freckles, lentigo or dark sports. Subjects must be able to attend monthly sessions in the period of 12 weeks session. 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. Subjects must refrain from receiving both ablative and nonablative laser treatment at least 3 months before the trial. Subjects who can apply sun screen with UVA and UVB protection that has a minimum of SPF30 daily. Exclusion Criteria: 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 Subjects with a congenital disease which darkens skin tone, e.g. Addison's disease, Cushing's syndrome and Thyrotoxicosis 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. Subjects who take pills that might cause hyperpigmentation such as chemotherapy, Amiodarone, Chlorpromazine, Hydroxychloroquine, Gold, Birth control pills (if related to causing hyperpigmentation issue) Female subjects with pregnancy and breastfeeding. Subjects who are allergic to chemical compound in the cream such as Alcohol denat, Phenoxyethanol or fragrance.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chinmanat Lekhavat, MD

Organizational Affiliation

Institute of Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Dermatology

City

Ratchathewi

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

12622786

Citation

Briganti S, Camera E, Picardo M. Chemical and instrumental approaches to treat hyperpigmentation. Pigment Cell Res. 2003 Apr;16(2):101-10. doi: 10.1034/j.1600-0749.2003.00029.x.

Results Reference

background

PubMed Identifier

21763992

Citation

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.

Results Reference

background

PubMed Identifier

16631967

Citation

Ortonne JP, Pandya AG, Lui H, Hexsel D. Treatment of solar lentigines. J Am Acad Dermatol. 2006 May;54(5 Suppl 2):S262-71. doi: 10.1016/j.jaad.2005.12.043.

Results Reference

background

PubMed Identifier

29427586

Citation

Mann T, Gerwat W, Batzer J, Eggers K, Scherner C, Wenck H, Stab F, Hearing VJ, Rohm KH, Kolbe L. Inhibition of Human Tyrosinase Requires Molecular Motifs Distinctively Different from Mushroom Tyrosinase. J Invest Dermatol. 2018 Jul;138(7):1601-1608. doi: 10.1016/j.jid.2018.01.019. Epub 2018 Feb 7.

Results Reference

background

PubMed Identifier

15117368

Citation

Lacz NL, Vafaie J, Kihiczak NI, Schwartz RA. Postinflammatory hyperpigmentation: a common but troubling condition. Int J Dermatol. 2004 May;43(5):362-5. doi: 10.1111/j.1365-4632.2004.02267.x. No abstract available.

Results Reference

background

PubMed Identifier

10691963

Citation

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.

Results Reference

background

PubMed Identifier

1402005

Citation

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.

Results Reference

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

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