Treatment of melasma with topical unani medicine.

Phase 2

Not yet recruiting

Conditions: Chloasma,

Registration Number: CTRI/2025/06/089523

Lead Sponsor: Luqmqn unani medical college hospital and research center

Brief Summary: Melasma (Kalaf)stands out as a significant and complex form of acquired hyperpigmentation, often encountered in general dermatology practices. Particularly in the Indian demographic, it emerges as the most prevalent pigmentary issue, typically affecting individuals in the age range of 30 to 40 years. (1,2) Melasma is a significant cosmetic issue that has widespread implications worldwide. (3) The precise prevalence of melasma in South Asia is still unclear, with estimates varying between 0.25% to 4%. In India, melasma is among the most common hyperpigmentary disorders, although specific prevalence figures differ among different regions. (4) Melasma affects approximately 5 to 6 million people in the United States alone, and its incidence is even greater globally. While it is more commonly seen in females, males make up about 10% of cases and demonstrate similar clinicopathological characteristics. (1,5) While melasma can affect individuals of all racial and ethnic backgrounds, it is more prevalent among those with darker skin tones, specifically skin types 4 to 5. This is especially true for Hispanic, Asian, and African populations living in areas with elevated levels of ultraviolet (UV) radiation. (4) Melasma typically shows a male-to-female ratio of 1:10, with most cases occurring during the third or fourth decade of life. However, lesions may also appear after the age of 40 or 50 in 14% and 6% of cases, respectively. (6) Melasma appears on the facial areas exposed to the sun, predominantly impacting the forehead, cheeks, temples, and jawline. It presents as symmetrically distributed dark brown patches, often with clear boundaries. The forehead, cheeks, upper lip, nose, and chin are frequently affected. (7,8,9) Clinically, melasma presents as irregular patches of brown, gray, or blue macules without signs of redness or irritation. (7,10) While it’s commonly linked to hormonal factors like oral contraceptive use or pregnancy, it can also occur in both men and women without hormonal influence. Previous understandings attributed hyperpigmentation solely to melanin in the epidermis, but recent research suggests that an increased quantity of melanocytes may also play a role in the observed epidermal hyperpigmentation in melasma. ((3,8,11,12,1314) Managing melasma is challenging and requires a prolonged treatment plan. Traditionally, there are several topical therapy options, such as hydroquinone, kojic acid, and azelaic acid, which are used as hypo-pigmenting agents. (15) Hydroquinone alone and triple combination cream (consisting of hydroquinone, tretinoin, and corticosteroid) are widely regarded as the most effective and established treatments for melasma. Chemical peels, laser, and light-based therapies are alternative options, but they carry a higher risk of adverse effects compared to topical treatments. (16) Traditional treatments for melasma carry the risk of adverse reactions. Hydroquinone, a frequently utilized agent, can result in dose and time-dependent effects like erythema, stinging, and paradoxical post-inflammatory hyper-melanosis. Concentrations of hydroquinone exceeding 2% may induce "confetti-like" depigmentation, while prolonged usage can lead to ochronosis. Topical corticosteroids, employed to alleviate irritation, may cause skin lightening and, when used extensively, can lead to skin atrophy and other complications. (17,18) In response to the limitations of conventional treatments for melasma, there is a growing interest in exploring alternative therapeutic options. Traditional medicine systems like Unani medicine offer potential remedies for melasma by drawing upon ancient healing practices. The primary aim of this study was to find a safe and effective treatment for melasma. Specifically, it sought to evaluate the safety and efficacy of a topical formulation combining Husn-i-Yusuf and Rogan-i- chambeli (19) through an open label randomized controlled trial titled "Therapeutic assessment of topical Husn-i-Yusuf with Rogan-i-Chambeli in managing Kalaf (melasma) – A randomized standard controlled trial."

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Both men and women are eligible Partipants aged between 18 to 50 years Individuals clinically diagnosed with melasma Participants able and willing to comprehend and adhere to the study protocol through out its duration.

Exclusion Criteria

Pregnant or breast feeding women based on history Individuals with a history of current presence of skin allergies or allergic reactions to hydroquinone Individualss with a history of current presence of severe diseases including immunological conditions like HIV existing malignancies diabetes mellitus hypertension etc participants who have used any topical or systemic treatments for scalp conditions within 15 daysprior to the baseline assessment patients with a history of chemical peels and facial laser treatments within the past 9 months as well as those who have used sun protection creams.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Melasma Area and Severity Index mMASI score	baseline 2nd 4th 6th and 8th weeks

Secondary Outcome Measures

Name	Time	Method
Change in IGA for melasma severity on 100mm VAS score	Baseline and after treatment
Change in dermatology life quality index DLQI

Trial Locations

Locations (1): Luqman unani hospital
🇮🇳
Bijapur, KARNATAKA, India
Luqman unani hospital
🇮🇳Bijapur, KARNATAKA, India
Dr Javeriya Azeem
Principal investigator
8792366335
juweriyaazeem@gmail.com