MelasmaPhase 1NCT05887219
Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
A Phase 1 study testing Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid and Group B Azelaic Acid 20 % Cream for 6 months in people with Melasma, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
Trial summary
Methodology: Fifty female patients presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face) diagnosed by consultant dermatologist on clinical presentation were included in this study. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Melasma
- What is being tested?
- Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid and Group B Azelaic Acid 20 % Cream for 6 months
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 30 Apr 2023
- Phase
- Phase 1
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients
- Aged 20 to 45 years
- Presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face)
- Diagnosed by consultant dermatologist on clinical presentation under wood's light.
Who cannot join
- Pregnant patients
- Women taking contraceptive pills at the time of study or past 12 months
- Any chronic illness
- Allergy to any of the agents used in the treatment
- Those taking any topical and systemic treatment for melasma in the last one month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Azelaic Acid 20% Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
Methodology: Fifty female patients presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face) diagnosed by consultant dermatologist on clinical presentation were included in this study. The sample size was calculated by WHO Sample Size calculator taking 31% proportion of excellent response with 4% hydroquinone as an adjuvant to oral tranexamic acid as compared to 2.25% proportion of excellent response with 20% azelaic acid, 80% power of test and 5% significance level. After randomization, patients were divided into two groups. Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) while group B was managed with topical 20% azelaic acid (daily at night) for six months. Clinical evaluation was done initially at the start of therapy and then at 2nd, 4th and 6th month using MASI score and patient's response. Efficacy was assessed in both groups at the end of therapy after six months.
- Conditions
- Melasma
- Being tested
- Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid, Group B Azelaic Acid 20 % Cream for 6 months
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic AcidDrug
Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) for 6 months
Group B Azelaic Acid 20 % Cream for 6 monthsDrug
Group B was managed with topical 20% azelaic acid (daily at night) for six months.
| Study group | Role | What they receive |
|---|---|---|
| Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid | Active comparator | Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) Receives: Drug: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid |
| Group B Azelaic Acid 20 % cream for 6 months | Active comparator | group B was managed with topical 20% azelaic acid (daily at night) for six months. Receives: Drug: Group B Azelaic Acid 20 % Cream for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melasma Area and Severity Index
Melasma Area and Severity Index Score was used to assess response to treatment.Lowest score=0,Highest Score 48. High score indicates worse outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Nov 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Nigar, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887219
- Sponsor's protocol ID
- CMHAbbottabad1987
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- 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 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Azelaic Acid 20% Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
- ClinicalTrials.gov ID
- NCT05887219
- Acronym / sponsor ID
- CMHAbbottabad1987
- Conditions
- Melasma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 Jun 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.
Methodology: Fifty female patients presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face) diagnosed by consultant dermatologist on clinical presentation were included in this study. The sample size was calculated by WHO Sample Size calculator taking 31% proportion of excellent response with 4% hydroquinone as an adjuvant to oral tranexamic acid as compared to 2.25% proportion of excellent response with 20% azelaic acid, 80% power of test and 5% significance level. After randomization, patients were divided into two groups. Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) while group B was managed with topical 20% azelaic acid (daily at night) for six months. Clinical evaluation was done initially at the start of therapy and then at 2nd, 4th and 6th month using MASI score and patient's response. Efficacy was assessed in both groups at the end of therapy after six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid | Active comparator | Drug: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic AcidGroup A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) |
| Group B Azelaic Acid 20 % cream for 6 months | Active comparator | Drug: Group B Azelaic Acid 20 % Cream for 6 monthsgroup B was managed with topical 20% azelaic acid (daily at night) for six months. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients
- Aged 20 to 45 years
- Presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face)
- Diagnosed by consultant dermatologist on clinical presentation under wood's light.
Key exclusion criteria (5 listed)
- Pregnant patients
- Women taking contraceptive pills at the time of study or past 12 months
- Any chronic illness
- Allergy to any of the agents used in the treatment
- Those taking any topical and systemic treatment for melasma in the last one month
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 |
|---|---|---|
| Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic AcidGroup A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) for 6 months | Drug | Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid |
| Group B Azelaic Acid 20 % Cream for 6 monthsGroup B was managed with topical 20% azelaic acid (daily at night) for six months. | Drug | Group B Azelaic Acid 20 % cream for 6 months |
Primary outcome
Melasma Area and Severity Index
Time frame: 6 months
Melasma Area and Severity Index Score was used to assess response to treatment.Lowest score=0,Highest Score 48. High score indicates worse outcome.
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 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid and Group B Azelaic Acid 20 % Cream for 6 months in people with Melasma, run by Combined Military Hospital Abbottabad 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 4 inclusion and 5 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 Jun 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Area and Severity Index (time frame: 6 months). 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 Jun 2023.