Evaluating efficacy of a Unani formulation in melasma.

Phase 2/3

Not yet recruiting

Lead Sponsor: National Research institute of Unani medicine for skin disorders

Brief Summary: *Kalaf* (Melasma) is a common acquired disorder of hyperpigmentation characterized by irregular light to dark brown macules on the sun exposed area of the face. The prevalence of melasma ranges from 8.8% to 40%.It affects all age population but mostly common in 21-44 years age group.Melasma affects all races especially Hispanics, Asians, Africans, Arab and mostly affects person with darker skin type. Exact cause of melasma is unknown, but various risk factors that play an important role to aggravate melasma *i.e.* uncontrolled sun exposure, pregnancy, hormonal influences, darker phenotype, genetic factors. It produces considerable impact on the patientâ€™s quality of life. It further produces psychological upset in the form of low self-esteem, nervousness, irritation, depression and anxiety. Melasma is a curable disease but it requires long term treatment. It has been observed that recurrence after cessation of treatment is a most common problem. Conventional therapy such as application of hydroquinone produces various side effects like dermatitis, post inflammatory pigmentation. Nowadays cosmetics having metal which are very dangerous to the health are being used. Hence it is felt that there is a need to search for safe and effective treatment for melasma.

Recruitment & Eligibility

Inclusion Criteria

Participant having single or multiple, symmetrical or asymmetrical brown macules on face, cheeks, nose, forehead, upper lip and chin.

Exclusion Criteria

a) Women who are pregnant, and lactating.
b) Participant aged <18 years or >55 years.
c) Significant cardiovascular/ pulmonary/ hepatorenal dysfunction.
d) Known case of diabetes mellitus, HIV/ AIDS and malignancy.
e) Those unwilling to come for regular follow-up for the entire duration of the study and any patients considered not eligible according to the investigatorâ€™s discretion during the study.

Primary Outcome Measures

Name	Time	Method
25% reduction in MASI score from the baseline after 8 weeks of treatment.	8 Weeks

Secondary Outcome Measures

Name	Time	Method
improvement in quality of life.	8 weeks

Locations (1): National Research institute of Unani medicine for skin disorders
🇮🇳
Hyderabad, TELANGANA, India
National Research institute of Unani medicine for skin disorders
🇮🇳Hyderabad, TELANGANA, India
Tatheer fatma
Principal investigator
7670967665
dr.tatheer.khan2008@gmail.com