Effect of DrugsPhase 2/3NCT04170088
Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma
A Phase 2/3 study testing Tranexamic Acid and 0.9% Normal Saline in people with Effect of Drugs and Adverse Effects of Medical Drugs, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
It is a randomized controlled trial in which investigators determine the efficacy of tranexamic acid (TA) by mesotherapy in comparison to normal saline on participants having Melasma. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Drugs, Adverse Effects of Medical Drugs
- What is being tested?
- Tranexamic Acid and 0.9% Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2018to 30 Jun 2019
- Phase
- Phase 2/3
- 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
- informed consent
- age between 18 to 55 years
- bilateral symmetrical mild to severe melasma
Who cannot join
- pregnancy and lactation
- history of taken any topical treatment for melasma in previous 1 month
- history of bleeding disorders
- concomitant use of anticoagulants,
- any known drug allergy especially to the study drug,
- having associated medical illnesses.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Jinnah potgraduate Medical Centre ( JINNAH HOPITAL)
Karachi, Sindh, 75510
About this study
Official title: Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma; a Split Face Study in Tertiary Care Hospital of Karachi
It is a randomized controlled trial in which investigators determine the efficacy of tranexamic acid (TA) by mesotherapy in comparison to normal saline on participants having Melasma.
Read the detailed description
In this prospective single blind split face controlled trial.Total 30 patients referred to Dermatology Ward were selected. At first, patients were examined under wood lamp for determination of melasma type (epidermal, dermal). Then, patients underwent Tranexamic acid microinjections with a concentration of TA 4 mg/ml with 0.9 % normal saline on their left half of the face and only 0.9%normal saline on their right half of the face, with mesotherapy technique. This procedure was done total of six times with 2-week intervals. Participants were assessed by Hemi Modified Melasma Area and Severity Scoring (mMASI) at start and end of the study for each half of face. Statistical Package for Social Sciences (SPSS) , version 23 was used for analysis. P value < 0.01 was taken significant.
- Conditions
- Effect of Drugs, Adverse Effects of Medical Drugs
- Being tested
- Tranexamic Acid, 0.9% Normal Saline
- Keywords
- Melasma, Tranexamic acid, Mesotherapy
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Normal saline
Tranexamic acid intradermal injections were used for treatment of melasma
0.9% Normal SalineDrug
Normal saline used for comparision of efficacy of tranexamic acid
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Left side of face of each participant was selected for intradermal Tranexamic acid injections.
generic name : Tranexamic acid Dose : 4mg / ml tranexamc acid diluted with 0.9 % normal saline Frequency : every 2 weekly total 6 doses. Duration : 6 months Receives: Drug: Tranexamic Acid; Drug: 0.9% Normal Saline |
| 0.9% Normal saline | Experimental | Right side of face of each participant was selected for intradermal normal saline injections generic name : Normal Saline Dose : 0.9 % Normal Saline Dose : Frequency : every 2 weekly total 6 doses. Duration : 6 months Receives: Drug: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HEMI-Modified Melasma Area and Severity Index (mMASI)
Calculation of Hemi mMASI score is performed by rating darkness and area of involvement of 3 areas of the each half of face. These figures are then inserted into an equation, resulting in the final Hemi mMASI score for both halves of face. Equation : forehead (0.15×D×A) + malar ( 0.30×D×A) + chin ( 0.05×D×A) The mean value of the data obtained from each half of the face was calculated and the mean percentage change was compared. Hemi-MASI score was used because of the study design of split-face, and it was calculated based on the percentage of the involved area Improvement was considered when there was reduction in mean hemi modified MASI score at both sides of face. Higher score was considered as worse and low score was considered as good in improvement of melasma.
At each follow-up visit, adverse events were also evaluated. Patients were asked to reports side effects such as erythema, burning, swelling, and change in menstrual cycle during and after treatment.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Sep 2018
- Primary completion1 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Effect of DrugsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- individual patients were selected in study . To control over confounding factors two sides of same patient were used parallel for intradermal injection ( Mesotherapy) of tranexamic acid and with normal saline
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Sana Kaleem, Jinnah Postgraduate Medical Centre
- Investigators
- rabia ghafoor, FCPS, Study director, Assistant Profesor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170088
- Sponsor's protocol ID
- F.2-81/2018-GENL/2522/JPMC
- Other IDs
- sana.dec04@hotmail.com
- Status last verified
- Nov 2019
- First submitted
- 17 Nov 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ogbechie-Godec OA, Elbuluk N. Melasma: an Up-to-Date Comprehensive Review. Dermatol Ther (Heidelb). 2017 Sep;7(3):305-318. doi: 10.1007/s13555-017-0194-1. Epub 2017 Jul 19.
PubMed 28726212Handel AC, Miot LD, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol. 2014 Sep-Oct;89(5):771-82. doi: 10.1590/abd1806-4841.20143063.
PubMed 25184917
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma; a Split Face Study in Tertiary Care Hospital of Karachi
- ClinicalTrials.gov ID
- NCT04170088
- Acronym / sponsor ID
- F.2-81/2018-GENL/2522/JPMC
- Conditions
- Effect of Drugs, Adverse Effects of Medical Drugs
- Keywords
- Melasma, Tranexamic acid, Mesotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 20 Nov 2019 (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.
It is a randomized controlled trial in which investigators determine the efficacy of tranexamic acid (TA) by mesotherapy in comparison to normal saline on participants having Melasma.
Detailed description
In this prospective single blind split face controlled trial.Total 30 patients referred to Dermatology Ward were selected. At first, patients were examined under wood lamp for determination of melasma type (epidermal, dermal). Then, patients underwent Tranexamic acid microinjections with a concentration of TA 4 mg/ml with 0.9 % normal saline on their left half of the face and only 0.9%normal saline on their right half of the face, with mesotherapy technique. This procedure was done total of six times with 2-week intervals. Participants were assessed by Hemi Modified Melasma Area and Severity Scoring (mMASI) at start and end of the study for each half of face. Statistical Package for Social Sciences (SPSS) , version 23 was used for analysis. P value < 0.01 was taken significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- individual patients were selected in study . To control over confounding factors two sides of same patient were used parallel for intradermal injection ( Mesotherapy) of tranexamic acid and with normal saline
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic Acid, Drug: 0.9% Normal SalineLeft side of face of each participant was selected for intradermal Tranexamic acid injections. generic name : Tranexamic acid Dose : 4mg / ml tranexamc acid diluted with 0.9 % normal saline Frequency : every 2 weekly total 6 doses. Duration : 6 months |
| 0.9% Normal saline | Experimental | Drug: 0.9% Normal SalineRight side of face of each participant was selected for intradermal normal saline injections generic name : Normal Saline Dose : 0.9 % Normal Saline Dose : Frequency : every 2 weekly total 6 doses. Duration : 6 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- informed consent
- age between 18 to 55 years
- bilateral symmetrical mild to severe melasma
Key exclusion criteria (6 listed)
- pregnancy and lactation
- history of taken any topical treatment for melasma in previous 1 month
- history of bleeding disorders
- concomitant use of anticoagulants,
- any known drug allergy especially to the study drug,
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 |
|---|---|---|
| Tranexamic AcidAlso: Normal salineTranexamic acid intradermal injections were used for treatment of melasma | Drug | Tranexamic acid |
| 0.9% Normal SalineNormal saline used for comparision of efficacy of tranexamic acid | Drug | 0.9% Normal saline, Tranexamic acid |
Primary outcome
Change in HEMI-Modified Melasma Area and Severity Index (mMASI)
Time frame: 10 months
Calculation of Hemi mMASI score is performed by rating darkness and area of involvement of 3 areas of the each half of face. These figures are then inserted into an equation, resulting in the final Hemi mMASI score for both halves of face. Equation : forehead (0.15×D×A) + malar ( 0.30×D×A) + chin ( 0.05×D×A) The mean value of the data obtained from each half of the face was calculated and the mean percentage change was compared. Hemi-MASI score was used because of the study design of split-face, and it was calculated based on the percentage of the involved area Improvement was considered when there was reduction in mean hemi modified MASI score at both sides of face. Higher score was considered as worse and low score was considered as good in improvement of melasma. At each follow-up visit, adverse events were also evaluated. Patients were asked to reports side effects such as erythema, burning, swelling, and change in menstrual cycle during and after treatment.
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 17 Dec 2019.
- Results publication: PubMed 28726212Ogbechie-Godec OA, Elbuluk N. Melasma: an Up-to-Date Comprehensive Review. Dermatol Ther (Heidelb). 2017 Sep;7(3):305-318. doi: 10.1007/s13555-017-0194-1. Epub 2017 Jul 19.
- Results publication: PubMed 25184917Handel AC, Miot LD, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol. 2014 Sep-Oct;89(5):771-82. doi: 10.1590/abd1806-4841.20143063.
- 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.
rabia ghafoor, FCPS study director
Assistant Profesor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic Acid and 0.9% Normal Saline in people with Effect of Drugs and Adverse Effects of Medical Drugs, run by Jinnah Postgraduate Medical Centre 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 6 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 17 Dec 2019. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in HEMI-Modified Melasma Area and Severity Index (mMASI) (time frame: 10 months). 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 NCT04170088, which also lists 2 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 17 Dec 2019.