Evaluation of the efficacy and safety of topical application of Tukhm-e-Turb and Tukhm-e-Jarjir in the management of Kalf (Melasma)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- • modified Melasma Area Severity Index (mMASI)
Study Overview
Brief Summary
Kalf (Melasma) is an acquired hyper melanotic condition that generally strikes women and is characterized by symmetrical light brown to grey brown macules or patches that form over the cheeks, around the eyes, at chin and across the forehead. As classified according to the location of the pigment, three types of melasma exist, namely, epidermal, dermal, and mixed. According to Unani system of medicine, Kalf commonly called as Jhae’en which develops by burnt blood that leaks from capillaries and pools up underneath the skin .
Despite the fact that melasma can affect people of all sexes and skin types, it is most prevalent among adult women with darker skin tones aged between 27 and 57 years. The prevalence of melasma is 1% in the general population and as high as 50% in high-risk populations. It varies from 0.25% to 4% in Southeast Asia. It is the most typical hyper pigmentary disorder among Indians, and the female-to-male ratio is around 4:1.
Due to the fact that melasma mostly affects the face, which causes patients to feel distressed, it has a negative impact on the patients’ quality of life, hurting their psychological and emotional well-being as well as social interactions. Sometimes this might lead the patient to feel shame, frustration, embarrassment, low self-esteem, and demotivation.
Regardless of the numerous treatment options available to treat melasma, it remains a medical concern. As it is recalcitrant to available treatments.
Kalf (Melasma) is treated in the Unani system of medicine with time-tested formulations that possess properties like Muṣaffῑ-i-Dam, Ghassᾱl, Moḥallil, Jᾱlῑ, and Mohassin e Lawn, which are quite effective and have no or fewer adverse effects. Therefore, there is a need to validate the Unani treatment on contemporary, scientifically validated, and reliable parameters. In addition to this, it is cost-effective, economical, and, by far, accessible and safe to use
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Clinically diagnosed patients of Kalf (Melasma) by wood’s lamp examination.
- •2 Patients with Fitzpatrick skin types III, IV and V 3 Patients of all sexes.
- •4 Patients who are willing to sign the written consent form prior to participation in the study.
Exclusion Criteria
- •1 Pregnant and lactating women.
- •2 Patients having used any cosmetic depigmenting agent within 2 weeks prior to inclusion in the study.
- •3 Female on oral contraceptives and hormone therapy at the time of study.
- •4 Patients having used topical or systemic corticosteroid within 1 month prior to inclusion in the study.
- •5 Patients having history of laser treatment or dermabrasion or deep facial peels within the past 3 months.
- •7 Patients who have a known history of renal insufficiency, severe liver or heart diseases, neurological disorders, malignancy, HIV infection, AIDS, etc.
- •8 Patients unlikely to comply with the study protocol.
Outcomes
Primary Outcomes
• modified Melasma Area Severity Index (mMASI)
Time Frame: Baseline,2nd week, 4th week and 6th week
• Patient Global
Time Frame: Baseline,2nd week, 4th week and 6th week
Assessment (PtGA)
Time Frame: Baseline,2nd week, 4th week and 6th week
Secondary Outcomes
- Melasma quality of life scale (MELASQoL)(Baseline and 6th week)
Investigators
Faiza Hussain
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital