Melasma (Facial Melasma)Phase 4NCT07508098
Comparison of Efficacy of Topical Westerhoff Formula Cream Vs Topical 4% Hydroquinone for the Treatment of Melasma
A Phase 4 study testing Triple combination cream and Hydroquinone 4% Cream in people with Melasma (Facial Melasma), run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial summary
study was conducted on middle aged male and female, including families and health care professional also. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Melasma (Facial Melasma)
- What is being tested?
- Triple combination cream and Hydroquinone 4% Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jul 2025to 19 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient with facial melasma of age between 15 years to 45 years of both gender
Who cannot join
- patient who have already taken treatment within 8 weeks, pregnant women, who are taking hormonals therapy and patient of dementia
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dermatology Department of Tertiary Care Hospital
Rawalpindi, Punjab Province, 46000
About this study
study was conducted on middle aged male and female, including families and health care professional also.
- Conditions
- Melasma (Facial Melasma)
- Being tested
- Triple combination cream, Hydroquinone 4% Cream
- Keywords
- MASI. Melasma. Westerhoff formula. 4 % Hydroquinone
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple combination creamDrug
4.7% N-acetylcysteine, 2% Hydroquinone and 0.1 % triamcinolone acetate twice daily for 8 weeks
Hydroquinone 4% CreamDrug
twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Triple combination group) | Experimental | participants in this arm will receive topical westerhoff formula cream which is combination of 4.7% of N-acetylcysteine, 2% hydroquinone and 0.1% Triamcinolone acetate twice daily for 8 weeks for the treatment of facial melasma Receives: Drug: Triple combination cream |
| Arm 2 (4 % Hydroquinone) | Active comparator | participant in this group will receive 4% hydroquinone twice daily for 8 weeks for the facial melasma. Receives: Drug: Hydroquinone 4% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of participants achieving 60% reduction in the melasma area severity index (MASI-60)
the primary outcome is the proportion of the participants achieving 60% reduction in MASI score from baseline after 8 weeks of treatment. MASI is the scoring system used to assess the melasma on the basis of severity darkness and the homogeneityenicity
Measured: 8 weeks
proportion of participants achieving >60% reduction in Melasma Area and severity index (MASI-60)
The primary outcome is the proportion of the participants achieving 60% reduction in MASI Score rom the baseline after treatment. MASI is the scoring system used to assess the severity of melasma based on the area, darkness nd the homogeneity
Measured: baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start18 Jul 2025
- Primary completion19 Jan 2026
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melasma (Facial Melasma)Studies 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
- Model description
- participants will be assigned to two parallel groups receiving either triple combination therapy or 4% hydroquinone cream and outcome will be compared between groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Syed Muzzamal Bukhari, Pak Emirates Military Hospital
- Investigators
- QAMMAR khan DR, MBBS. FCPS(Dermatalogy), Study director, Pak Emirates Military HospitalMoizza tHAIR Dr, MBBS.FCPS(Dermatology), Study chair, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508098
- Sponsor's protocol ID
- PakEmiratesMH.westerhoff
- Other IDs
- PEMH hospital rawalpindi
- Status last verified
- Jul 2025
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identify patient data, MASI and treatment allocation
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Topical Westerhoff Formula Cream Vs Topical 4% Hydroquinone for the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT07508098
- Acronym / sponsor ID
- PakEmiratesMH.westerhoff
- Conditions
- Melasma (Facial Melasma)
- Keywords
- MASI. Melasma. Westerhoff formula. 4 % Hydroquinone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 2 Apr 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.
study was conducted on middle aged male and female, including families and health care professional also.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- participants will be assigned to two parallel groups receiving either triple combination therapy or 4% hydroquinone cream and outcome will be compared between groups
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Triple combination group) | Experimental | Drug: Triple combination creamparticipants in this arm will receive topical westerhoff formula cream which is combination of 4.7% of N-acetylcysteine, 2% hydroquinone and 0.1% Triamcinolone acetate twice daily for 8 weeks for the treatment of facial melasma |
| Arm 2 (4 % Hydroquinone) | Active comparator | Drug: Hydroquinone 4% Creamparticipant in this group will receive 4% hydroquinone twice daily for 8 weeks for the facial melasma. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patient with facial melasma of age between 15 years to 45 years of both gender
Key exclusion criteria (1 listed)
- patient who have already taken treatment within 8 weeks, pregnant women, who are taking hormonals therapy and patient of dementia
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 |
|---|---|---|
| Triple combination cream4.7% N-acetylcysteine, 2% Hydroquinone and 0.1 % triamcinolone acetate twice daily for 8 weeks | Drug | Arm 1 (Triple combination group) |
| Hydroquinone 4% Creamtwice daily for 8 weeks | Drug | Arm 2 (4 % Hydroquinone) |
Primary outcome
proportion of participants achieving 60% reduction in the melasma area severity index (MASI-60)
Time frame: 8 weeks
the primary outcome is the proportion of the participants achieving 60% reduction in MASI score from baseline after 8 weeks of treatment. MASI is the scoring system used to assess the melasma on the basis of severity darkness and the homogeneityenicity
proportion of participants achieving >60% reduction in Melasma Area and severity index (MASI-60)
Time frame: baseline to 8 weeks
The primary outcome is the proportion of the participants achieving 60% reduction in MASI Score rom the baseline after treatment. MASI is the scoring system used to assess the severity of melasma based on the area, darkness nd the homogeneity
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 2 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identify patient data, MASI and treatment allocation
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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.
QAMMAR khan DR, MBBS. FCPS(Dermatalogy) study director
Pak Emirates Military Hospital
Moizza tHAIR Dr, MBBS.FCPS(Dermatology) study chair
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 4 study testing Triple combination cream and Hydroquinone 4% Cream in people with Melasma (Facial Melasma), run by Pak Emirates Military 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 1 inclusion and 1 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 2 Apr 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?
proportion of participants achieving 60% reduction in the melasma area severity index (MASI-60) (time frame: 8 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?
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 2 Apr 2026.