comparsion between two drugs for the treatment of facial pigmentation

Phase 1

Not yet recruiting

Conditions: Chloasma,

Registration Number: CTRI/2021/08/035625

Lead Sponsor: ROHAILKHAND MEDICAL COLLEGE

Brief Summary: Melasma is a common, subtle, symptomless, evenness, and patterned hyperpigmentation. It has predisposition for involvement of the cheeks, forearm, nose, upper lip, and forhead arises as asymmetrical shaped, but many of times it is markedly described, speckles of dark to light brown pigmentation in the fair complexion or dark ones in dark complexion individuals. It may be idiopathic, may appear during pregnancy or be associated with use of oral contraceptives . It Affects almost all the races, but it is more commonly seen in Hispanics and Asians with skin types IV, V, and VI with centrofacial , malar, and mandibular distribution. ultraviolet (UV) radiation have some role in occurrence of melasma in case of non pregnant women and in men.1

It is most prevalent in Southeast Asia, in 40 % in females and 20% in males. In Asia, aesthetic consultation of melasma are 50% . Occurs in 50-70% of pregnant women in USA and in 50 to 80 % of Latina women. Despite the fact melasma is developed after pregnancy in 41% of females and spontaneous remission is found only in 8% of the cases. In case of Prevalence it is on side in females with a male to female ratio of approximately 4:1. Women with multiple pregnancies have higher incidence (51%) compared with single women (25%) or with no pregnancy (24%).2

Based on the distribution of the facial lesions, melasma can be classified into three types, namely malar, centrofacial, and mandibular patterns. Melasma can be classified as epidermal, dermal, mixed, and indeterminate variants on the basis of woodâ€™s lamp examination.

Treatment of melasma is tough because of its dermal constituent and propensity to recurrence. The most usual therapy in treating melasma is to use broad-spectrum (UVA & UVB) sunscreen , as is topical hydroquinone used very often . Retinoic acid (tretinoin) and azelaic acid are the opposite lightening agents employed in melasma.To increase the efficacy while treating the melasma combination therapies such as tretinoin, azelaic acid , hydroquinone and steriods have been used as compared with monotherapy. Kojic acid, isopropylhcatechol, N-acetyl-4-cysteaminylphenol, and flavonoid extracts are Other compounds that have been isopropylcatechol, N- acetyl-4- cysteaminylphenol .4

Different techniques like depigmenting agents ( Hydroquinone , kojic and azelaic acids,) and keratolytic agents (tretinoine, glycolic and trichloroacetic acids) are being used but chemical peeling provides more rapid response than topical therapy. Chemical peels create injury at a specific skin depth and causes exfoliation that stimulates new epidermal growth and collagen with more even distribution of melanin .5

On histologic finding of melasma is increase melanin content in of both dermis and epidermis, but the quantity varies with the severity of hyperpigmentation. In, most of the studies manifest no quantifiable rise in melanocytes; however, the melanosomes are more copious and cells are enlarged with distinguished and broaden dendrites. In additional to color change other finding are solar elastosis and photoaging, expression of endothelial growth factors and increased mast cells in dermal blood vessels.6

Diagnosis and evaluation of treatment of melasma can be made by clinical examination, photography, woods lamp examination, dermoscopy and confocal microscopy. The severity of melasma can be estimated using colorimetry, mexametry and calculation of melasma area severity index (MASI).7

Since very few clinical trials based on the comparative study of efficacy and tolerability of hydroquinone and kojic acid have been performed, the centre of this study is mostly on the effectivness of topical kojic acid and hydroquinone acid, so as to determine an effective modality of treatment for melasma. Moreover, previous studies mainly focused on multidrug therapy and not on monotherapeutic drug therapy which has less side effects and are sufficiently less costly and this study is based on monotherapeutic drug therapy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Those who are willing for study 2.
Moderate to severe melasma 3.
Age (18-60) years.
Mentally stable, oriented and coherent patients.

Exclusion Criteria

Pregnancy and Lactation 2.
Melasma inducing drugs.
Patients on photosensitizing drugs or thyroid hormones.
Patients on Hormone replacement therapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To reduce the Melasma Area and Severity Index (MASI) Score	4 month

Secondary Outcome Measures

Name	Time	Method
To improve the quality of life of the patients	6 months

Trial Locations

Locations (1): Rohilkhand medical college and hospital
🇮🇳
Bareilly, UTTAR PRADESH, India
Rohilkhand medical college and hospital
🇮🇳Bareilly, UTTAR PRADESH, India
POOJA SUHAG
Principal investigator
05812526153
drpoojasuhag@gmail.com