MedPath

A study on patients suffering from Melasma (a skin problem caused by brown to gray-brown patches on the face) to determine efficacy and safety of 2 skin care products which are Cysteamine cream with Hydroquinone cream.

Phase 4
Conditions
Health Condition 1: L811- ChloasmaHealth Condition 2: L814- Other melanin hyperpigmentation
Registration Number
CTRI/2024/04/066500
Lead Sponsor
Cutis Institute of Dermatology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients who meet following criteria will be randomized in the study-

1. Indian adult subjects aged 18 to 60 years

2. Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up)

3. With healthy intact skin on the studied anatomic unit (free of eczema, wounds, inflammation)

4. Patients willing to provide informed consent

Exclusion Criteria

Patients who do not meet following criteria will be randomized in the study-

1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.

2. Having refused to give consent by not signing the consent form.

3. Taking part in another study liable to interfere with this study.

4. Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)

5. Having progressive asthma.

6. Being epileptic.

7. Having non-stabilized thyroid disease (requirement of a stabilized treatment for at least 6 months)

8. Having cutaneous hypersensitivity to study ingredients

9. Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products.

10. Following a chronic medical treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath