Effectiveness and Safety of Isobutylamido-thiazolyl-resorcinol Cream 0.2% for Melasma and Facial Hyperpigmentation

• Status: Not yet recruiting
• Trial end date: 2019-10-29
• Target enrollment: 200
• Participant gender: All

Summary

Melasma and facial hyperpigmentation (dark spots) are common skin issues that can cause embarrassment and affect the quality of life in majority of people. We are conducting a research to study an effectiveness and safety of Isobutylamido-thiazolyl-resorcinol 0.2% in the treatment of melasma, freckles, lentigo and dark spots in comparison to vehicle intervention in 4, 8 and 12-week period. Our ultimate goal is to provide the best medical treatments to improve physical and mental health for the people who suffer from melasma and facial hyperpigmentation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute of Dermatology, Thailand
• Collaborator: Beiersdorf (Thailand) Co., Ltd.

Criteria

Inclusion Criteria:

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

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

3. Subjects must be able to attend monthly treatment 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 dark marks caused by other factors 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 melasma issue)

5. Female subjects with pregnancy and breastfeeding.

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

7. Subjects who are allergic to perfume or perfume products.