MelasmaPhase 1NCT05362500
Comparison of Chemical Peeling Agent With Transamine for Treatment of Melasma
A Phase 1 study testing Glycolic Acid 70% and Tranexamic acid injection in people with Melasma, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
Trial summary
Melasma is an acquired skin disorder characterized by hyper-melanosis. Melasma is a term that originates from the Greek root "melas" (black color) and was formerly known as chloasma. Melasma is more common in sun-exposed tissues such as the cheeks, chin, upper lip, and forehead. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Melasma
- What is being tested?
- Glycolic Acid 70% and Tranexamic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2021to 30 Nov 2021
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients suffering from Melasma who attended the Dermatology department
Who cannot join
- history of hormone therapy and contraceptive pills (within the previous 12 months)
- bleeding problems or concurrent use of anticoagulants
- Topical treatment such as hydroquinone (one month prior to the research)
- Active herpes simplex, face warts or active dermatoses
- History of hypersensitivity to some of the study's components
- Pregnant or lactating females
- Patients with unrealistic expectations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Chemical Peeling With 70% Glycolic Acid and Intradermal Transamine for the Treatment of Melasma.
Melasma is an acquired skin disorder characterized by hyper-melanosis. Melasma is a term that originates from the Greek root "melas" (black color) and was formerly known as chloasma. Melasma is more common in sun-exposed tissues such as the cheeks, chin, upper lip, and forehead. Melasma is a common dermatological disorder with a frequency of 8.8 percent in the United States, but it can be as high as 40 percent amongst females. Melasma affects mostly ladies and is most common throughout their reproductive years .
Melasma causes an increase in melanin pigment synthesis owing to a surge in the number of melanosomes, which are membrane-bound cell organelles inside melanocytes where melanin biosynthesis occurs and is transported to keratinocytes. Except in rare situations, the number of melanocytes will not be enhanced. Melanocytes will grow in size, and dendrites will become more visible. Despite the fact that the specific causation is unknown, some elements are thought to have a role in the pathophysiological mechanisms of melasma). Among these, sun exposure (UV light) is the most powerful primary trigger for its growth, which explains melisma's propensity for certain areas of the body. Other major determinants include genetic predisposition, and female hormones - both endogenous (that is, during pregnancy) and exogenous (that is, during pregnancy) (contraceptives and hormone replacement therapy). Thyroid problems, medications, and cosmetics can all be aggravating factors. Evaluation and prevention of triggering variables are essential in order to avoid recurrence .
Read more
The peeling effect of glycolic acid is due to chemo exfoliation capabilities, that rely upon aiding the elimination of keratinocytes, resulting in melanin reduction and speeding up the regeneration of skin. TA suppresses UV-stimulated plasmin action in keratin cells by blocking plasminogen appending to the keratin cells, resulting from lower free arachidonic acid levels or to reduced capacity of prostaglandins production, which reduces melanocyte tyrosinase activity .
The study's implications are to analyze the efficacy of these two drugs in order to assess the better outcome of patients with evidence-based management.
Read the detailed description
A randomized controlled trial study (single-blind) was done In the Dermatology Unit of the CMH, Abbottabad from June to November 2021 after Ethical Review Board approval, the 54 patients aged 20-50 years after informed consent were enrolled using a technique of non-probability consecutive sampling. The sample size was determined using the WHO sample size calculator, With a significance level of 95%, power of study 80%, the ratio of sample size B: A of 1 and Assumed MASI score in Group A (Tranexamic Acid) Mean + SD = 9.37 ± 2.18, in Group B (Glycolic Acid 70%) Mean + SD = 10.25 ± 2.93. Thus, the required sample size was 54 (27 in each group).
For randomization, the final recruited 54 participants (38 females, 16 males; aged 20-50 years), recruited into two groups i.e. Group A: contain 27 patients which had been treated every 2 weeks for 12 weeks with 70% glycolic acid to assess chemical peeling and cold water was used for washing to stop peeling as displayed and Group B: contain 27 patients treated with an intradermal injection of 0.05 mL of tranexamic acid solution in normal saline (4 mg/mL) into the melasma lesion at 1 cm distance using a sterile insulin syringe, weekly for 12 weeks .
- Conditions
- Melasma
- Being tested
- Glycolic Acid 70%, Tranexamic acid injection
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycolic Acid 70%Drug
Also called Peeling agent
Group A: contain 27 patients which had been treated every 2 weeks for 12 weeks with 70% glycolic acid to assess chemical peeling and cold water was used for washing
Tranexamic acid injectionDrug
Also called transamine injection
Group B: contain 27 patients treated with an intradermal injection of 0.05 mL of tranexamic acid solution in normal saline (4 mg/mL) into the melasma lesion at 1 cm distance using a sterile insulin syringe, weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A 70% Glycolic acid | Active comparator | Group A: contain 27 patients which had been treated every 2 weeks for 12 weeks with 70% glycolic acid to assess chemical peeling and cold water was used for washing to stop peeling Receives: Drug: Glycolic Acid 70% |
| Group B intradermal tranexamic acid | Active comparator | Group B: contain 27 patients treated with an intradermal injection of 0.05 mL of tranexamic acid solution in normal saline (4 mg/mL) into the melasma lesion at 1 cm distance using a sterile insulin syringe, weekly for 12 weeks Receives: Drug: Tranexamic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of 70%glycolic acid and intradermal transamine for treatment of melasma as assessed by MODIFIED MELASMA SEVERITY INDEX (mMASI)
Modified melasma severity index was used to measure effectiveness of both drugs.
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 posted5 May 2022
- Study start1 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naheed khan, Combined Military Hospital Abbottabad
- Investigators
- Naheed Khan, Principal investigator, Cpsp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362500
- Sponsor's protocol ID
- CMHatd-ETH-22-derm-22
- Other IDs
- 131/CPSP
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 5 May 2022
- 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Chemical Peeling With 70% Glycolic Acid and Intradermal Transamine for the Treatment of Melasma.
- ClinicalTrials.gov ID
- NCT05362500
- Acronym / sponsor ID
- CMHatd-ETH-22-derm-22
- Conditions
- Melasma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 5 May 2022 (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.
Melasma is an acquired skin disorder characterized by hyper-melanosis. Melasma is a term that originates from the Greek root "melas" (black color) and was formerly known as chloasma. Melasma is more common in sun-exposed tissues such as the cheeks, chin, upper lip, and forehead. Melasma is a common dermatological disorder with a frequency of 8.8 percent in the United States, but it can be as high as 40 percent amongst females. Melasma affects mostly ladies and is most common throughout their reproductive years .
Melasma causes an increase in melanin pigment synthesis owing to a surge in the number of melanosomes, which are membrane-bound cell organelles inside melanocytes where melanin biosynthesis occurs and is transported to keratinocytes. Except in rare situations, the number of melanocytes will not be enhanced. Melanocytes will grow in size, and dendrites will become more visible. Despite the fact that the specific causation is unknown, some elements are thought to have a role in the pathophysiological mechanisms of melasma). Among these, sun exposure (UV light) is the most powerful primary trigger for its growth, which explains melisma's propensity for certain areas of the body. Other major determinants include genetic predisposition, and female hormones - both endogenous (that is, during pregnancy) and exogenous (that is, during pregnancy) (contraceptives and hormone replacement therapy). Thyroid problems, medications, and cosmetics can all be aggravating factors. Evaluation and prevention of triggering variables are essential in order to avoid recurrence .
The peeling effect of glycolic acid is due to chemo exfoliation capabilities, that rely upon aiding the elimination of keratinocytes, resulting in melanin reduction and speeding up the regeneration of skin. TA suppresses UV-stimulated plasmin action in keratin cells by blocking plasminogen appending to the keratin cells, resulting from lower free arachidonic acid levels or to reduced capacity of prostaglandins production, which reduces melanocyte tyrosinase activity .
The study's implications are to analyze the efficacy of these two drugs in order to assess the better outcome of patients with evidence-based management.
Detailed description
A randomized controlled trial study (single-blind) was done In the Dermatology Unit of the CMH, Abbottabad from June to November 2021 after Ethical Review Board approval, the 54 patients aged 20-50 years after informed consent were enrolled using a technique of non-probability consecutive sampling. The sample size was determined using the WHO sample size calculator, With a significance level of 95%, power of study 80%, the ratio of sample size B: A of 1 and Assumed MASI score in Group A (Tranexamic Acid) Mean + SD = 9.37 ± 2.18, in Group B (Glycolic Acid 70%) Mean + SD = 10.25 ± 2.93. Thus, the required sample size was 54 (27 in each group).
For randomization, the final recruited 54 participants (38 females, 16 males; aged 20-50 years), recruited into two groups i.e. Group A: contain 27 patients which had been treated every 2 weeks for 12 weeks with 70% glycolic acid to assess chemical peeling and cold water was used for washing to stop peeling as displayed and Group B: contain 27 patients treated with an intradermal injection of 0.05 mL of tranexamic acid solution in normal saline (4 mg/mL) into the melasma lesion at 1 cm distance using a sterile insulin syringe, weekly for 12 weeks .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A 70% Glycolic acid | Active comparator | Drug: Glycolic Acid 70%Group A: contain 27 patients which had been treated every 2 weeks for 12 weeks with 70% glycolic acid to assess chemical peeling and cold water was used for washing to stop peeling |
| Group B intradermal tranexamic acid | Active comparator | Drug: Tranexamic acid injectionGroup B: contain 27 patients treated with an intradermal injection of 0.05 mL of tranexamic acid solution in normal saline (4 mg/mL) into the melasma lesion at 1 cm distance using a sterile insulin syringe, weekly for 12 weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients suffering from Melasma who attended the Dermatology department
Key exclusion criteria (7 listed)
- history of hormone therapy and contraceptive pills (within the previous 12 months)
- bleeding problems or concurrent use of anticoagulants
- Topical treatment such as hydroquinone (one month prior to the research)
- Active herpes simplex, face warts or active dermatoses
- History of hypersensitivity to some of the study's components
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 |
|---|---|---|
| Glycolic Acid 70%Also: Peeling agentGroup A: contain 27 patients which had been treated every 2 weeks for 12 weeks with 70% glycolic acid to assess chemical peeling and cold water was used for washing | Drug | Group A 70% Glycolic acid |
| Tranexamic acid injectionAlso: transamine injectionGroup B: contain 27 patients treated with an intradermal injection of 0.05 mL of tranexamic acid solution in normal saline (4 mg/mL) into the melasma lesion at 1 cm distance using a sterile insulin syringe, weekly for 12 weeks | Drug | Group B intradermal tranexamic acid |
Primary outcome
Effectiveness of 70%glycolic acid and intradermal transamine for treatment of melasma as assessed by MODIFIED MELASMA SEVERITY INDEX (mMASI)
Time frame: 12 weeks
Modified melasma severity index was used to measure effectiveness of both drugs.
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 5 May 2022.
- 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)
Active, not recruitingPhase 4
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.
Naheed Khan principal investigator
Cpsp
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 Glycolic Acid 70% and Tranexamic acid injection 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 1 inclusion and 7 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 5 May 2022. 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?
Effectiveness of 70%glycolic acid and intradermal transamine for treatment of melasma as assessed by MODIFIED MELASMA SEVERITY INDEX (mMASI) (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 5 May 2022.