MelasmaPhase 4NCT03923062
Different Dermatological Approaches the Treatment of Melasma
A Phase 4 study testing chemicalpeeling, cryopeeling and microneedling in people with Melasma, run by Assiut University.
Trial summary
To compare the efficacy and safety of cryopeeling (using Liquid Nitrogen) and tranexemic acid (cyclokapron) versus chemical peeling (using TCA 20%) in treatment of melasma. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Melasma
- What is being tested?
- chemicalpeeling, cryopeeling and microneedling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Dec 2020
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Subjects presented with melasma.
- Age 20-40 years old.
- Melasma persisting for more than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents.
Who cannot join
- -History of photosensitivity, keloids, hypertrophic scarring and post- inflammatory hyperpigmentation.
- Pregnancy and lactation.
- Subjects with local inflammatory skin disorder or active herpes infection at the site of procedure.
- Subjects with history of medical diseases which contraindicate cryosurgery such as; cold intolerance, cold urticaria, Raynaud's disease and history of allergic reactions to cryosurgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Different Dermatological Approaches in Treatment of Melasma: A Split Face Randomized Clinical Trial
To compare the efficacy and safety of cryopeeling (using Liquid Nitrogen) and tranexemic acid (cyclokapron) versus chemical peeling (using TCA 20%) in treatment of melasma.
Read the detailed description
Melasma is a common, acquired, circumscribed hypermelanosis of the sun-exposed skin, It presents as symmetric, hyperpigmented macules having irregular, serrated, and geographic borders , The most common locations are the cheeks, upper lips, the chin and the forehead, but other sun-exposed areas may also be occasionally involved .
Studies has indicated the role of several risk factors such as genetics, sunlight, age, gender, hormones, pregnancy, thyroid dysfunction, cosmetics and medications .
Histologic features of melasma include an increase in the content of both epidermal and dermal melanin, but the quantity varies with the intensity of hyperpigmentation. In addition, most studies show no quantitative increase in melanocytes; however, the cells are enlarged with prominent and elongated dendrites and more abundant melanosomes. Additional features of the involved skin include solar elastosis and increased mast cells, dermal blood vessels, and expression of vascular endothelial growth factor.
Commonly used topical agents for the treatment of melasma include hydroquinone, azelaic acid, kojic acid, glycolic acid, salicylic acid and tretinoin. Of these treatments, hydroquinone remains the gold standard .Second-line treatments, such as chemical peels and lasers, are efficacious in some patients .
Chemical peeling is the application of a chemical agent to the skin, which causes the controlled destruction of a part or of the entire epidermis with or without the dermis, leading to exfoliation and removal of superficial lesions, followed by regeneration of new epidermal and dermal tissues [khunger, 2008]. The mechanism of action in melasma is the removal of unwanted melanin via controlled chemical burn of the skin .
Trichloroacetic acid has been used as a peeling agent for a long time and is still the most effective and safest agent for medium peeling, Its depth of penetration depends on the TCA concentration and on the preparation of the skin, specially the degreasing. Between 10% and 30% concentration is considered a superficial peel; above 30% provides a medium-depth peel.
Cryopeeling is a technique that uses cryotherapy in a diffuse manner throughout the skin region affected by sun damage in order to promote cell renewal and desquamation, with possible benefits in the appearance of new lesions caused by photodamage. Up to the investigator's knowledge, few studies were performed evaluating such technique.
Recently, trans-4-(Aminomethyl) cyclohexanecarboxylic acid, or tranexamic acid (TA), has been proposed as a new treatment for melasma.The main mechanism of the hypopigmentant effects of TA is due to its antiplasmin activity .In addition, TA is similar to tyrosine in a portion of its structure, which can inhibit tyrosinase competitively .Also, Plasmin transforms the vascular endothelial growth factor (VEGF) into a diffusing form, and histological examination showed that TA plays an important role in the reduction of erythema and vascularities and the number of mast cell in the dermis.Various forms of TA are used orally, topically and as a microinjection for the treatment of melasma.
- Conditions
- Melasma
- Being tested
- chemicalpeeling, cryopeeling, microneedling
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemicalpeelingDevice
Also called chemical peeling using Trichloroacetic acid 20%
Cleansing and degreasing the face with alcohol .
- The patients must be sitting at an angle of 45.
- A 2 × 2 cm cotton gauze will be used to apply TCA 20%.
- We will apply the acid from the midline to the right side of the forehead and under the right eye, covering the right cheek and perioral area.
- We then will wait for a few minutes and will observe the frost developing.
- The patient will be then allowed to wash her face.
cryopeelingDevice
Also called cryopeeling using Liquid Nitrogen
Cryopeeling will be performed by spraying the freezing substance(Liquid Nitrogen) on the face at 1-2cm distance and moving along the affected area until freezing appear.
microneedlingCombination product
Also called microneedling using tranxemic acid
Tranexamic acid will be used in aconcentration of 4mg/ml ,1ml will be used fo half of the face.
- After gentle cleansing, topical analgesic cream will be applied over the area to be treated.
- The microneedles will be used, the skin will be stretched and microneedling will be carried out in vertical, horizontal, and both diagonal directions for about four to five times. Tranexamic acid, 0.5 to 1 ml (4 mg/mL), will be applied over this area, and the procedure will be repeated four to five times in the above-said directions
| Study group | Role | What they receive |
|---|---|---|
| G I A (right side): will be treated by chemical peeling | Experimental | right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration). Receives: Device: chemicalpeeling |
| G I B(left side):will be treated by cryopeeling | Experimental | left side of the patient's face will be treated by cryopeeling using Liquid Nitrogen. Receives: Device: cryopeeling |
| G II A (right side): will be treated by chemical peeling | Experimental | right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration). Receives: Device: chemicalpeeling |
| G II B (left side):will be treated by tranexemic acid | Experimental | left side of patient's face will be treated by tranexemic acid(cyclokapron) Receives: Combination Product: microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
melasma area and severity index (MASI)
Clinical evaluation of melasma severity will be done by melasma area severity index (MASI) every session and at the end of treatment.
No response, no improvement.
- Mild response, <25% improvement.
- Moderate response, 25% to < 50% improvement.
- Good response, 50% to < 75% improvement.
- Very good response, >75% improvement.
Measured: baseline
photo of the patient
photo of the patient before and after treatment
Measured: baseline
Biopsy
A punch biopsy will be taken from affected area for histipathological examination
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Feb 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Hafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923062
- Sponsor's protocol ID
- DDATM
- Status last verified
- Jan 2020
- First submitted
- 1 Apr 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim EH, Kim YC, Lee ES, Kang HY. The vascular characteristics of melasma. J Dermatol Sci. 2007 May;46(2):111-6. doi: 10.1016/j.jdermsci.2007.01.009. Epub 2007 Mar 23.
PubMed 17363223Hexsel D, Rodrigues TC, Dal'Forno T, Zechmeister-Prado D, Lima MM. Melasma and pregnancy in southern Brazil. J Eur Acad Dermatol Venereol. 2009 Mar;23(3):367-8. doi: 10.1111/j.1468-3083.2008.02885.x. Epub 2008 Jul 7. No abstract available.
PubMed 18631207Sheth VM, Pandya AG. Melasma: a comprehensive update: part I. J Am Acad Dermatol. 2011 Oct;65(4):689-697. doi: 10.1016/j.jaad.2010.12.046.
PubMed 21920241Moin A, Jabery Z, Fallah N. Prevalence and awareness of melasma during pregnancy. Int J Dermatol. 2006 Mar;45(3):285-8. doi: 10.1111/j.1365-4632.2004.02470.x.
PubMed 16533230Sheth VM, Pandya AG. Melasma: a comprehensive update: part II. J Am Acad Dermatol. 2011 Oct;65(4):699-714. doi: 10.1016/j.jaad.2011.06.001.
PubMed 21920242Sarkar R, Bansal S, Garg VK. Chemical peels for melasma in dark-skinned patients. J Cutan Aesthet Surg. 2012 Oct;5(4):247-53. doi: 10.4103/0974-2077.104912.
PubMed 23378706Monheit GD, Chastain MA. Chemical peels. Facial Plast Surg Clin North Am. 2001 May;9(2):239-55, viii.
PubMed 11457690Perper M, Eber AE, Fayne R, Verne SH, Magno RJ, Cervantes J, ALharbi M, ALOmair I, Alfuraih A, Nouri K. Tranexamic Acid in the Treatment of Melasma: A Review of the Literature. Am J Clin Dermatol. 2017 Jun;18(3):373-381. doi: 10.1007/s40257-017-0263-3.
PubMed 28283893Na JI, Choi SY, Yang SH, Choi HR, Kang HY, Park KC. Effect of tranexamic acid on melasma: a clinical trial with histological evaluation. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1035-9. doi: 10.1111/j.1468-3083.2012.04464.x. Epub 2012 Feb 13.
PubMed 22329442Sharma YK, Gupta A. Some Other Serendipitous Discoveries in Dermatology. Indian J Dermatol. 2016 Jan-Feb;61(1):95-6. doi: 10.4103/0019-5154.174045. No abstract available.
PubMed 26955108
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Dermatological Approaches in Treatment of Melasma: A Split Face Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03923062
- Acronym / sponsor ID
- DDATM
- Conditions
- Melasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 22 Apr 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.
To compare the efficacy and safety of cryopeeling (using Liquid Nitrogen) and tranexemic acid (cyclokapron) versus chemical peeling (using TCA 20%) in treatment of melasma.
Detailed description
Melasma is a common, acquired, circumscribed hypermelanosis of the sun-exposed skin, It presents as symmetric, hyperpigmented macules having irregular, serrated, and geographic borders , The most common locations are the cheeks, upper lips, the chin and the forehead, but other sun-exposed areas may also be occasionally involved .
Studies has indicated the role of several risk factors such as genetics, sunlight, age, gender, hormones, pregnancy, thyroid dysfunction, cosmetics and medications .
Histologic features of melasma include an increase in the content of both epidermal and dermal melanin, but the quantity varies with the intensity of hyperpigmentation. In addition, most studies show no quantitative increase in melanocytes; however, the cells are enlarged with prominent and elongated dendrites and more abundant melanosomes. Additional features of the involved skin include solar elastosis and increased mast cells, dermal blood vessels, and expression of vascular endothelial growth factor.
Commonly used topical agents for the treatment of melasma include hydroquinone, azelaic acid, kojic acid, glycolic acid, salicylic acid and tretinoin. Of these treatments, hydroquinone remains the gold standard .Second-line treatments, such as chemical peels and lasers, are efficacious in some patients .
Chemical peeling is the application of a chemical agent to the skin, which causes the controlled destruction of a part or of the entire epidermis with or without the dermis, leading to exfoliation and removal of superficial lesions, followed by regeneration of new epidermal and dermal tissues [khunger, 2008]. The mechanism of action in melasma is the removal of unwanted melanin via controlled chemical burn of the skin .
Trichloroacetic acid has been used as a peeling agent for a long time and is still the most effective and safest agent for medium peeling, Its depth of penetration depends on the TCA concentration and on the preparation of the skin, specially the degreasing. Between 10% and 30% concentration is considered a superficial peel; above 30% provides a medium-depth peel.
Cryopeeling is a technique that uses cryotherapy in a diffuse manner throughout the skin region affected by sun damage in order to promote cell renewal and desquamation, with possible benefits in the appearance of new lesions caused by photodamage. Up to the investigator's knowledge, few studies were performed evaluating such technique.
Recently, trans-4-(Aminomethyl) cyclohexanecarboxylic acid, or tranexamic acid (TA), has been proposed as a new treatment for melasma.The main mechanism of the hypopigmentant effects of TA is due to its antiplasmin activity .In addition, TA is similar to tyrosine in a portion of its structure, which can inhibit tyrosinase competitively .Also, Plasmin transforms the vascular endothelial growth factor (VEGF) into a diffusing form, and histological examination showed that TA plays an important role in the reduction of erythema and vascularities and the number of mast cell in the dermis.Various forms of TA are used orally, topically and as a microinjection for the treatment of melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G I A (right side): will be treated by chemical peeling | Experimental | Device: chemicalpeelingright sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration). |
| G I B(left side):will be treated by cryopeeling | Experimental | Device: cryopeelingleft side of the patient's face will be treated by cryopeeling using Liquid Nitrogen. |
| G II A (right side): will be treated by chemical peeling | Experimental | Device: chemicalpeelingright sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration). |
| G II B (left side):will be treated by tranexemic acid | Experimental | Combination Product: microneedlingleft side of patient's face will be treated by tranexemic acid(cyclokapron) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- -Subjects presented with melasma.
- Age 20-40 years old.
- Melasma persisting for more than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents.
Key exclusion criteria (4 listed)
- -History of photosensitivity, keloids, hypertrophic scarring and post- inflammatory hyperpigmentation.
- Pregnancy and lactation.
- Subjects with local inflammatory skin disorder or active herpes infection at the site of procedure.
- Subjects with history of medical diseases which contraindicate cryosurgery such as; cold intolerance, cold urticaria, Raynaud's disease and history of allergic reactions to cryosurgery.
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 |
|---|---|---|
| chemicalpeelingAlso: chemical peeling using Trichloroacetic acid 20%Cleansing and degreasing the face with alcohol . * The patients must be sitting at an angle of 45. * A 2 × 2 cm cotton gauze will be used to apply TCA 20%. * We will apply the acid from the midline to the right side of the forehead and under the right eye, covering the right cheek and perioral area. * We then will wait for a few minutes and will observe the frost developing. * The patient will be then allowed to wash her face. | Device | G I A (right side): will be treated by chemical peeling, G II A (right side): will be treated by chemical peeling |
| cryopeelingAlso: cryopeeling using Liquid NitrogenCryopeeling will be performed by spraying the freezing substance(Liquid Nitrogen) on the face at 1-2cm distance and moving along the affected area until freezing appear. | Device | G I B(left side):will be treated by cryopeeling |
| microneedlingAlso: microneedling using tranxemic acidTranexamic acid will be used in aconcentration of 4mg/ml ,1ml will be used fo half of the face. * After gentle cleansing, topical analgesic cream will be applied over the area to be treated. * The microneedles will be used, the skin will be stretched and microneedling will be carried out in vertical, horizontal, and both diagonal directions for about four to five times. Tranexamic acid, 0.5 to 1 ml (4 mg/mL), will be applied over this area, and the procedure will be repeated four to five times in the above-said directions | Combination product | G II B (left side):will be treated by tranexemic acid |
Primary outcome
melasma area and severity index (MASI)
Time frame: baseline
Clinical evaluation of melasma severity will be done by melasma area severity index (MASI) every session and at the end of treatment. No response, no improvement. * Mild response, <25% improvement. * Moderate response, 25% to < 50% improvement. * Good response, 50% to < 75% improvement. * Very good response, >75% improvement.
photo of the patient
Time frame: baseline
photo of the patient before and after treatment
Biopsy
Time frame: baseline
A punch biopsy will be taken from affected area for histipathological examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 17363223Kim EH, Kim YC, Lee ES, Kang HY. The vascular characteristics of melasma. J Dermatol Sci. 2007 May;46(2):111-6. doi: 10.1016/j.jdermsci.2007.01.009. Epub 2007 Mar 23.
- Background: PubMed 18631207Hexsel D, Rodrigues TC, Dal'Forno T, Zechmeister-Prado D, Lima MM. Melasma and pregnancy in southern Brazil. J Eur Acad Dermatol Venereol. 2009 Mar;23(3):367-8. doi: 10.1111/j.1468-3083.2008.02885.x. Epub 2008 Jul 7. No abstract available.
- Background: PubMed 21920241Sheth VM, Pandya AG. Melasma: a comprehensive update: part I. J Am Acad Dermatol. 2011 Oct;65(4):689-697. doi: 10.1016/j.jaad.2010.12.046.
- Background: PubMed 16533230Moin A, Jabery Z, Fallah N. Prevalence and awareness of melasma during pregnancy. Int J Dermatol. 2006 Mar;45(3):285-8. doi: 10.1111/j.1365-4632.2004.02470.x.
- Background: PubMed 21920242Sheth VM, Pandya AG. Melasma: a comprehensive update: part II. J Am Acad Dermatol. 2011 Oct;65(4):699-714. doi: 10.1016/j.jaad.2011.06.001.
- Background: PubMed 23378706Sarkar R, Bansal S, Garg VK. Chemical peels for melasma in dark-skinned patients. J Cutan Aesthet Surg. 2012 Oct;5(4):247-53. doi: 10.4103/0974-2077.104912.
- Background: PubMed 11457690Monheit GD, Chastain MA. Chemical peels. Facial Plast Surg Clin North Am. 2001 May;9(2):239-55, viii.
- Background: PubMed 28283893Perper M, Eber AE, Fayne R, Verne SH, Magno RJ, Cervantes J, ALharbi M, ALOmair I, Alfuraih A, Nouri K. Tranexamic Acid in the Treatment of Melasma: A Review of the Literature. Am J Clin Dermatol. 2017 Jun;18(3):373-381. doi: 10.1007/s40257-017-0263-3.
- Background: PubMed 22329442Na JI, Choi SY, Yang SH, Choi HR, Kang HY, Park KC. Effect of tranexamic acid on melasma: a clinical trial with histological evaluation. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1035-9. doi: 10.1111/j.1468-3083.2012.04464.x. Epub 2012 Feb 13.
- Background: PubMed 26955108Sharma YK, Gupta A. Some Other Serendipitous Discoveries in Dermatology. Indian J Dermatol. 2016 Jan-Feb;61(1):95-6. doi: 10.4103/0019-5154.174045. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chemicalpeeling, cryopeeling and microneedling in people with Melasma, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa Hafez, M.B.B.CH (01013881659 ext. 0020, shimaahafez75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
melasma area and severity index (MASI) (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT03923062, which also lists 10 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 13 Jan 2020.