| CTRI Number |
CTRI/2025/06/089523 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani Other (Specify) [Topical unani formulation ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of melasma with topical unani medicine. |
|
Scientific Title of Study
|
Therapeutic assessment of topical Husn-i-Yusuf with Rogan-i-Chambeli in managing Kalaf (melasma) - A randomized standard
controlled trial. |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Javeriya Azeem |
| Designation |
Pg Scholar |
| Affiliation |
Luqman unani medical college and research center |
| Address |
Luqman unani medical college hospital and research center 12 naubag opp star function hall vijaypura karnataka
Bijapur KARNATAKA 586101 India |
| Phone |
8792366335 |
| Fax |
|
| Email |
juweriyaazeem@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr dafedar abdur rehman |
| Designation |
Associate professor |
| Affiliation |
Luqman unani medical college and research center |
| Address |
Luqman unani medical college hospital and research center 12 naubag opp star function hall vijaypura karnataka
Bijapur KARNATAKA 585101 India |
| Phone |
9032786832 |
| Fax |
|
| Email |
drdafedar1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr saba mamdapur |
| Designation |
Professor |
| Affiliation |
Luqman unani medical college and research center |
| Address |
Luqman unani medical college hospital and research center 12 naubag opp star function hall vijaypura karnataka
Bijapur KARNATAKA 585101 India |
| Phone |
9611497816 |
| Fax |
|
| Email |
dr.sabamamdapur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Luqman unani medical college hospital and research center 12 naubag opp star function hall bijapur 586101 karnataka india |
|
|
Primary Sponsor
|
| Name |
Luqmqn unani medical college hospital and research center |
| Address |
Luqmqn unani medical college hospital and research center vijayapur karnataka 586101 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Javeriya Azeem |
Luqman unani hospital |
1st OPD of department of moalijat Luqman unani hospital 12 naubag opp star function hall bijapur 586101 karnataka india Bijapur KARNATAKA |
8792366335
juweriyaazeem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethical Committee for Bio Medical Reseach |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Husn-i-Yusuf with Rogan-i-Chambeli |
Husn-i-yusuf will be finely ground and sieved to create a powder which will then be mixed with clarified
Roghan-i-chambeli until a consistent paste
Application Method Applied topically
Dosage Apply a sufficient quantity 1-2g twice daily
Duration of Application 20 minutes
Follow-up at the Baseline 2nd 4th 6th and 8th weeks |
| Comparator Agent |
Hydroquinone 4% |
Formulation Cream
Application Method Applied topically
Duration of Application 20 minutes
Dosage Apply a sufficient quantity twice daily
Follow-up Scheduled at the Baseline 2nd 4th 6th and 8th weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Melasma Area and Severity Index mMASI score |
baseline 2nd 4th 6th and 8th weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in dermatology life quality index DLQI
|
Baseline and after treatment |
| Change in IGA for melasma severity on 100mm VAS score |
Baseline and after treatment |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/07/2027 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [juweriyaazeem@gmail.com].
- For how long will this data be available start date provided 02-01-2028 and end date provided 05-01-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
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." |