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

NCT03926845 | Completed

• 1 other identifier: 013/2562
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Hyperpigmentation

Keywords

Isobutylamido-thiazolyl-resorcinol

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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

  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

  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.

  12 weeks

Study Arms (2)

Isobutylamido-thiazolyl-resorcinol Cream 0.2%

ACTIVE COMPARATOR

The cream contains 0.2% Isobutylamido-thiazolyl-resorcinol.

Other: Isobutylamido-thiazolyl-resorcinol Cream 0.2%

Vehicle

PLACEBO COMPARATOR

The cream contains no active ingredients.

Other: Vehicle

Interventions

Isobutylamido-thiazolyl-resorcinol Cream 0.2% OTHER

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

Isobutylamido-thiazolyl-resorcinol Cream 0.2%

Vehicle OTHER

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

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Dermatology, Thailand: lead
• Beiersdorf (Thailand) Co., Ltd.: collaborator

Study Sites (1)

Institute of Dermatology

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (8)

• 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.

  PMID: 12622786 BACKGROUND

• 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.

  PMID: 21763992 BACKGROUND

• 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.

  PMID: 16631967 BACKGROUND

• 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.

  PMID: 29427586 BACKGROUND

• 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.

  PMID: 15117368 BACKGROUND

• 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.

  PMID: 10691963 BACKGROUND

• 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.

  PMID: 1402005 BACKGROUND

• Lekhavat C, Rojanamatin J, Suphannaphong M, Kolbe L. Efficacy and Tolerability of 0.2% Thiamidol Cream for Facial Hyperpigmentation: A Randomized, Double-Blind, and Vehicle-Controlled Study. Dermatol Ther (Heidelb). 2026 Jan 21. doi: 10.1007/s13555-025-01649-y. Online ahead of print.

  PMID: 41566113 DERIVED

Study Officials

• Chinmanat Lekhavat, MD

  Institute of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: April 29, 2019
• Primary Completion: November 30, 2020
• Study Completion: January 31, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

TH (1)