MelasmaPhase 2NCT05790577
Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma
A Phase 2 study testing Metformin and Nicotinamide vs Kligman Formula in people with Melasma, run by Ishtiaq Ahmed at 1 site in Pakistan.
Trial summary
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Metformin and Nicotinamide vs Kligman Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 15 Feb 2023
- Phase
- Phase 2
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-50
- No systemic therapy
- All Co-morbids
Who cannot join
- Pregnancy
- Age >50
- Taking oral treatment for melasma
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
Read the detailed description
A comparative study to evaluate Efficacy and tolerability of new lotion in the treatment of Melasma.
- Conditions
- Melasma
- Being tested
- Metformin and Nicotinamide vs Kligman Formula
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin and Nicotinamide vs Kligman FormulaDrug
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
| Study group | Role | What they receive |
|---|---|---|
| Metformin 30% and 2% Nicotinamispde | Active comparator | Metformin 30% plus Nicotinamide 2% in the reatment of Melasma Receives: Drug: Metformin and Nicotinamide vs Kligman Formula |
| Kligman formula | Active comparator | Kligman formula in the treatment of Melasma Receives: Drug: Metformin and Nicotinamide vs Kligman Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
Efficacy with measurement of MASI score 4 weeks apart
Measured: 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 Mar 2023
- Study start1 Feb 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ishtiaq Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ishtiaq Ahmed, Pak Emirates Military Hospital
- Investigators
- Ishtiaq Ahmed, MBBS, Study director, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790577
- Sponsor's protocol ID
- PakEmiratesMH2
- Status last verified
- May 2023
- First submitted
- 6 Aug 2022
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT05790577
- Acronym / sponsor ID
- PakEmiratesMH2
- Conditions
- Melasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ishtiaq AhmedUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 30 Mar 2023 (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.
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
Detailed description
A comparative study to evaluate Efficacy and tolerability of new lotion in the treatment of Melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin 30% and 2% Nicotinamispde | Active comparator | Drug: Metformin and Nicotinamide vs Kligman FormulaMetformin 30% plus Nicotinamide 2% in the reatment of Melasma |
| Kligman formula | Active comparator | Drug: Metformin and Nicotinamide vs Kligman FormulaKligman formula in the treatment of Melasma |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-50
- No systemic therapy
- All Co-morbids
Key exclusion criteria (3 listed)
- Pregnancy
- Age >50
- Taking oral treatment for melasma
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 |
|---|---|---|
| Metformin and Nicotinamide vs Kligman FormulaComparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma | Drug | Kligman formula, Metformin 30% and 2% Nicotinamispde |
Primary outcome
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
Time frame: 12 weeks
Efficacy with measurement of MASI score 4 weeks apart
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 23 May 2023.
- Individual participant dataSharing planned: No
Related trials for Melasma
Enrolling by invitationPhase 4
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
Melasma (Facial Melasma)
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Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)
Not yet recruiting
COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA
Melasma
Not yet recruiting
New Treatment in Melasma
Female, With
Not yet recruitingPhase 4
Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial Melasma
Melasma
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.
Ishtiaq Ahmed, MBBS study director
Pak Emirates Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and Nicotinamide vs Kligman Formula in people with Melasma, run by Ishtiaq Ahmed 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 3 inclusion and 3 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 23 May 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2023.