MelasmaPhase 4NCT07676994
Efficacy of New Trio Combination for Melasma
A Phase 4 study testing New trio combination and Kligman's formula (trio) in people with Melasma, run by Ghurki Trust and Teaching Hospital at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if the drug New Trio Combination (0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone) works to treat melasma. It will also learn about the safety of drug. Read more about this study
- Who is it for?
- Ages 16 to 60 years, women only
- Conditions the study is for
- Melasma
- What is being tested?
- New trio combination and Kligman's formula (trio)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 7 May 2025to 1 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female gender
- Age range: 16-60 years
Who cannot join
- Pregnant females
- Lactating mothers
- Those taking oral contraceptive pills and phenytoin
- Lost to follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of New Trio Combination Versus Kligman's Formula In Treatment of Melasma
The goal of this clinical trial is to learn if the drug New Trio Combination (0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone) works to treat melasma. It will also learn about the safety of drug. This drug lowers the pigmentation severity by measuring modified Melasma Area and Severity Index (mMASI) reduction by up to 50%. The possible side effects of this drug are erythema and burning. We will compare this drug to kligman's formula (5% hydroquinon, 0.1% retinoic acid and 0.1% dexamethasone) to see if New Trio Combination works to treat melasma patients. All subjects will be divided in two groups. Group 1 will receive New trio combination (NT) and group 2 will receive Kligman's formula (KG), once daily (night time application) for 3 months. Patients will be called for follow up at 4, 8 and 12 weeks.
A total of 56 patients fulfilling the inclusion criteria are enrolled in the study. Efficacy of New Trio Combination versus Kligman's Formula will be measured in all selected patients suffering from melasma by estimating improvement in the modified MASI score and MELASQoL at each follow up.
- Conditions
- Melasma
- Being tested
- New trio combination, Kligman's formula (trio)
- Keywords
- melasma, New Trio Combination, Kligman's Formula
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New trio combinationDrug
New trio combination is a drug containing 0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone
Kligman's formula (trio)Drug
Kligman's formula (trio) is a drug containing 5% hydroquinone, 0.1% retinoic acid and 0.1% dexamethason
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Group A | Experimental | Group A will receive New trio combination (NT) once daily Receives: Drug: New trio combination |
| Control Group: Group B | Active comparator | Group B will receive Kligman's formula (KG), once daily Receives: Drug: Kligman's formula (trio) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melasma Quality of Life (MELASQoL)
Melasma Quality of Life Scale (MELASQoL) will be used to assess the burden of melasma on patient's quality of life.
Measured: Responses will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks
modified Melasma Area and Severity Index (mMASI)
Melasma severity will be assessed by modified Melasma Area and Severity Index (mMASI).
Measured: Melasma severity over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, 8 weeks, and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start7 May 2025
- Primary completion7 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghurki Trust and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Meshaal Azhar, Principal investigator, Ghurki Trust Teaching HospitalProf. Dr. Haroon Nabi, Study director, Lahore Medical and Dental CollegeDr Aliza Hamadani, Study chair, Lahore Medical and Dental CollegeDr. Iram Kausar, Study chair, Ghurki Trust Teaching HospitalDr. Ayesha Asad Chattha, Study chair, Ghurki Trust Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676994
- Sponsor's protocol ID
- R-22
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwon SH, Na JI, Choi JY, Park KC. Melasma: Updates and perspectives. Exp Dermatol. 2019 Jun;28(6):704-708. doi: 10.1111/exd.13844. Epub 2018 Dec 21.
PubMed 30422338Banavase Channakeshavaiah R, Andanooru Chandrappa NK. Topical metformin in the treatment of melasma: A preliminary clinical trial. J Cosmet Dermatol. 2020 May;19(5):1161-1164. doi: 10.1111/jocd.13145. Epub 2019 Sep 10.
PubMed 31502392Shokier DA, Mohamed HF, Badria FA. Is Topical Metformin Effective in Treatment of Melasma? The Egyptian Journal of Hospital Medicine. 2023 Jan 1;90(1):1407-12.
Bertold C, Fontas E, Singh T, Gastaut N, Ruitort S, Wehrlen Pugliese S, Passeron T. Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2601-2607. doi: 10.1111/jdv.19455. Epub 2023 Sep 4.
PubMed 37620285
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of New Trio Combination Versus Kligman's Formula In Treatment of Melasma
- ClinicalTrials.gov ID
- NCT07676994
- Acronym / sponsor ID
- R-22
- Conditions
- Melasma
- Keywords
- melasma, New Trio Combination, Kligman's Formula
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ghurki Trust and Teaching HospitalUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 7 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the drug New Trio Combination (0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone) works to treat melasma. It will also learn about the safety of drug. This drug lowers the pigmentation severity by measuring modified Melasma Area and Severity Index (mMASI) reduction by up to 50%. The possible side effects of this drug are erythema and burning. We will compare this drug to kligman's formula (5% hydroquinon, 0.1% retinoic acid and 0.1% dexamethasone) to see if New Trio Combination works to treat melasma patients. All subjects will be divided in two groups. Group 1 will receive New trio combination (NT) and group 2 will receive Kligman's formula (KG), once daily (night time application) for 3 months. Patients will be called for follow up at 4, 8 and 12 weeks.
A total of 56 patients fulfilling the inclusion criteria are enrolled in the study. Efficacy of New Trio Combination versus Kligman's Formula will be measured in all selected patients suffering from melasma by estimating improvement in the modified MASI score and MELASQoL at each follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Group A | Experimental | Drug: New trio combinationGroup A will receive New trio combination (NT) once daily |
| Control Group: Group B | Active comparator | Drug: Kligman's formula (trio)Group B will receive Kligman's formula (KG), once daily |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Female gender
- Age range: 16-60 years
Key exclusion criteria (4 listed)
- Pregnant females
- Lactating mothers
- Those taking oral contraceptive pills and phenytoin
- Lost to follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New trio combinationNew trio combination is a drug containing 0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone | Drug | Intervention Group: Group A |
| Kligman's formula (trio)Kligman's formula (trio) is a drug containing 5% hydroquinone, 0.1% retinoic acid and 0.1% dexamethason | Drug | Control Group: Group B |
Primary outcome
Melasma Quality of Life (MELASQoL)
Time frame: Responses will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks
Melasma Quality of Life Scale (MELASQoL) will be used to assess the burden of melasma on patient's quality of life.
modified Melasma Area and Severity Index (mMASI)
Time frame: Melasma severity over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, 8 weeks, and 12 weeks.
Melasma severity will be assessed by modified Melasma Area and Severity Index (mMASI).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 30422338Kwon SH, Na JI, Choi JY, Park KC. Melasma: Updates and perspectives. Exp Dermatol. 2019 Jun;28(6):704-708. doi: 10.1111/exd.13844. Epub 2018 Dec 21.
- Background: PubMed 31502392Banavase Channakeshavaiah R, Andanooru Chandrappa NK. Topical metformin in the treatment of melasma: A preliminary clinical trial. J Cosmet Dermatol. 2020 May;19(5):1161-1164. doi: 10.1111/jocd.13145. Epub 2019 Sep 10.
- BackgroundShokier DA, Mohamed HF, Badria FA. Is Topical Metformin Effective in Treatment of Melasma? The Egyptian Journal of Hospital Medicine. 2023 Jan 1;90(1):1407-12.
- Background: PubMed 37620285Bertold C, Fontas E, Singh T, Gastaut N, Ruitort S, Wehrlen Pugliese S, Passeron T. Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2601-2607. doi: 10.1111/jdv.19455. Epub 2023 Sep 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Meshaal Azhar principal investigator
Ghurki Trust Teaching Hospital
Prof. Dr. Haroon Nabi study director
Lahore Medical and Dental College
Dr Aliza Hamadani study chair
Lahore Medical and Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing New trio combination and Kligman's formula (trio) in people with Melasma, run by Ghurki Trust and Teaching Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melasma Quality of Life (MELASQoL) (time frame: Responses will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07676994, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.