MelasmaPhase 4NCT04823520
Trichloroacetic Acid (TCA) Combined With Microdermabrasion in Treatment of Melasma
A Phase 4 study testing TCA in people with Melasma, run by Assiut University.
Trial summary
1. To detect the efficacy and safety of combined TCA and MDA in treating melasma. 2. To compare the efficacy and safety of using different TCA concentrations (15% \& 20%) alone and in combination with MDA in treatment of melasma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melasma
- What is being tested?
- TCA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 30 Sep 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of 18 years and above with bilateral melasma
- Clinical diagnosis of melasma.
- Mental capacity to give informed consent.
Who cannot join
- Pregnant or nursing women
- Current use of hormonal birth control medication or any hormonal therapy
- History of laser or dermabrasion to the face within 9 months of study enrollment
- Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids
- Photosensitivity.
- Patients with unrealistic expectations All the included patients will be subjected to detailed history taking,dermatological examination and Wood's light examination to estimate the depth (epidermal, dermal or mixed) of melasma.
Trial locations and contacts
No sites are listed yet.
About this study
- To detect the efficacy and safety of combined TCA and MDA in treating melasma.
- To compare the efficacy and safety of using different TCA concentrations (15% \& 20%) alone and in combination with MDA in treatment of melasma.
Read the detailed description
Melasma is a common, acquired hypermelanosis that occurs in sun exposed areas, mostly on the face, occasionally on the neck, and rarely on the forearms.
Melasma is generally a clinical diagnosis consisting of symmetric reticulated hypermelanosis in three predominant facial patterns: Centro facial, malar, and mandibular The major clinical pattern in 50-80% of cases is the Centro facial pattern, which affects the forehead, nose, and upper lip .
The malar pattern is restricted to the malar cheeks on the face, while mandibular melasma is present on the jawline and chin .
A newer pattern termed extra-facial melasma can occur on non-facial body parts, including the neck, sternum, forearms, and upper extremities .
Using the Wood's light examination, melasma can be classified into four major histological types depending upon the depth of pigment deposition:The epidermal type, in which the pigmentation is intensified under Wood's light, is the most common type. The epidermal type is the most responsive to treatment.
Key etiologic factors include a genetic predisposition, solar damage, barrier abnormalities, and unique sensitivities to hormonal changes including pregnancy, oral contraceptives, and hormone replacement therapy.
Melasma is often difficult to treat, and the condition may be refractory. Despite a strong therapeutic demand, the treatment of melasma remains highly challenging with inconsistent results and almost constant relapses. The treatment of melasma should include a multimodality approach that incorporates photoprotective agents, antioxidant treatments, skin lighteners, exfoliants, and resurfacing procedures, as needed. Evidence-based studies suggest that first line therapies for melasma encompass intense photoprotection and topical lightening agents.
Many depigmenting agents and other therapies such as chemical peeling are used for treating melasma, in the form of mono or combined therapy .
The most commonly used peeling agents are alpha-hydroxy-acids, glycolic acid, Jessner solution, salicylic acid, trichloroacetic acid (TCA), pyruvic acid and phenol .
Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction. Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction.
Chemical peeling is a promising treatment for numerous pigmentary disorders as melasma. It aims to remove the melanin rather than the inhibition of melanocytes or melanogenesis by causing controlled necrosis and subsequent regeneration of the epidermis, apart from remodeling of collagen and elastic fibers in the dermis .
TCA is widely used peeling agent in treatment of hyperpigmentation especially melasma. It is a keratolytic acid which cause precipitation of proteins and coagulation necrosis of the epidermis that leads to reepithelization with replacement of smoother skin with an even skin tone .It is not expensive, stable, not light-sensitive and does not need to be neutralized .
Microdermabrasion (MDA) is a minimally invasive epidermal resurfacing procedure used to treat uneven skin tone/texture, photo aging, striae, melasma, and scars.Microdermabrasion uses a variable flow of vacuum suction to maintain contact with the skin whilst the crystals (or diamond tips) get to work by smoothing and buffing the skin's surface.The crystals (or diamond tips) cause gentle mechanical abrasion to the skin, which ultimately removes the stratum corneum layer of the epidermis. As part of the wound healing process, new epidermis forms with enhanced cosmoses. The technique is considered safe for all Fitzpatrick skin types and complications are minimal. In addition to the cosmetic benefits of MDA, studies have also shown improved skin permeability and enhanced delivery of transdermal medications dosed on an area of the skin treated with MDA. Microdermabrasion removes the stratum corneum, the outermost layer of the epidermis . MDA has also been shown to affect deeper layers of the epidermis and dermis. MDA causes a re-arrangement of melanosomes in the basal layer of the epidermis, flattening of rete ridges at the dermal-epidermal junction, increased collagen fiber density at the dermal-epidermal junction, and vascular ectasia in the reticular dermis .
- Conditions
- Melasma
- Being tested
- TCA
- Keywords
- TCA, Chemical peeling, Microdermabrasion, Trichloroacetic acid, MELASMA, MDA
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCADrug
Also called MIcrodermabrasion (MDA)
All patients will receive 6 sessions at 2 weeks intervals,the half face which will recieve MDA and TCA,MDA will be done before appling TCA.
| Study group | Role | What they receive |
|---|---|---|
| Group 15% concentration | Active comparator | 30 patients MDA will be done to one half of the face then TCA 15% will be applied to the whole face. Receives: Drug: TCA |
| Group 20 % concentration | Active comparator | 30 patients will receive MDA to one side of the face , TCA 20% will then be applied to the whole face. Receives: Drug: TCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
"EFFICACY of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma "
To detect the efficacy of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma.
Clinical photographs: Front, right and left views of face of each patient will be photographed at baseline, every two weeks and one month after the last session with and high resolution digital camera in natural light.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion30 Sep 2022 (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
- Model description
- (Group 1): 30 patients MDA will be done to one half of the face then TCA 15% will be applied to the whole face. (Group 2): 30 patients will receive MDA to one side of the face , TCA 20% will then be applied to the whole face.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823520
- Sponsor's protocol ID
- TCA & MDA to treat melasma
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bandyopadhyay D. Topical treatment of melasma. Indian J Dermatol. 2009;54(4):303-9. doi: 10.4103/0019-5154.57602.
PubMed 20101327Sanchez NP, Pathak MA, Sato S, Fitzpatrick TB, Sanchez JL, Mihm MC Jr. Melasma: a clinical, light microscopic, ultrastructural, and immunofluorescence study. J Am Acad Dermatol. 1981 Jun;4(6):698-710. doi: 10.1016/s0190-9622(81)70071-9.
PubMed 6787100Guinot C, Cheffai S, Latreille J, Dhaoui MA, Youssef S, Jaber K, Nageotte O, Doss N. Aggravating factors for melasma: a prospective study in 197 Tunisian patients. J Eur Acad Dermatol Venereol. 2010 Sep;24(9):1060-9. doi: 10.1111/j.1468-3083.2010.03592.x. Epub 2010 Feb 25.
PubMed 20202051Tamega Ade A, Miot LD, Bonfietti C, Gige TC, Marques ME, Miot HA. Clinical patterns and epidemiological characteristics of facial melasma in Brazilian women. J Eur Acad Dermatol Venereol. 2013 Feb;27(2):151-6. doi: 10.1111/j.1468-3083.2011.04430.x. Epub 2012 Jan 3.
PubMed 22212073Mandry Pagan R, Sanchez JL. Mandibular melasma. P R Health Sci J. 2000 Sep;19(3):231-4.
PubMed 11076368Ritter CG, Fiss DV, Borges da Costa JA, de Carvalho RR, Bauermann G, Cestari TF. Extra-facial melasma: clinical, histopathological, and immunohistochemical case-control study. J Eur Acad Dermatol Venereol. 2013 Sep;27(9):1088-94. doi: 10.1111/j.1468-3083.2012.04655.x. Epub 2012 Jul 24.
PubMed 22827850Lapeere H, Boone B, Schepper SD.(2018) : Hypomelanosis and hypermelanosis. In: Wolff K,Goldsmith LA, Katz SI, editors.Dermatology in general medicine. 7th ed. New York: McGraw Hill. p. 635
Lebwohl M, Heymann W, Berth-Jones J. Treatment of skin disease: Comprehensive therapeutic strategies. St. Louis, MO: Mosby; 2002.
Molinar VE, Taylor SC, Pandya AG. What's new in objective assessment and treatment of facial hyperpigmentation? Dermatol Clin. 2014 Apr;32(2):123-35. doi: 10.1016/j.det.2013.12.008.
PubMed 24679999Jutley GS, Rajaratnam R, Halpern J, Salim A, Emmett C. Systematic review of randomized controlled trials on interventions for melasma: an abridged Cochrane review. J Am Acad Dermatol. 2014 Feb;70(2):369-73. doi: 10.1016/j.jaad.2013.07.044.
PubMed 24438951
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trichloroacetic Acid (TCA) Combined With Microdermabrasion in Treatment of Melasma
- ClinicalTrials.gov ID
- NCT04823520
- Acronym / sponsor ID
- TCA & MDA to treat melasma
- Conditions
- Melasma
- Keywords
- TCA, Chemical peeling, Microdermabrasion, Trichloroacetic acid, MELASMA, MDA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 30 Mar 2021 (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 detect the efficacy and safety of combined TCA and MDA in treating melasma.
- To compare the efficacy and safety of using different TCA concentrations (15% \& 20%) alone and in combination with MDA in treatment of melasma.
Detailed description
Melasma is a common, acquired hypermelanosis that occurs in sun exposed areas, mostly on the face, occasionally on the neck, and rarely on the forearms.
Melasma is generally a clinical diagnosis consisting of symmetric reticulated hypermelanosis in three predominant facial patterns: Centro facial, malar, and mandibular The major clinical pattern in 50-80% of cases is the Centro facial pattern, which affects the forehead, nose, and upper lip .
The malar pattern is restricted to the malar cheeks on the face, while mandibular melasma is present on the jawline and chin .
A newer pattern termed extra-facial melasma can occur on non-facial body parts, including the neck, sternum, forearms, and upper extremities .
Using the Wood's light examination, melasma can be classified into four major histological types depending upon the depth of pigment deposition:The epidermal type, in which the pigmentation is intensified under Wood's light, is the most common type. The epidermal type is the most responsive to treatment.
Key etiologic factors include a genetic predisposition, solar damage, barrier abnormalities, and unique sensitivities to hormonal changes including pregnancy, oral contraceptives, and hormone replacement therapy.
Melasma is often difficult to treat, and the condition may be refractory. Despite a strong therapeutic demand, the treatment of melasma remains highly challenging with inconsistent results and almost constant relapses. The treatment of melasma should include a multimodality approach that incorporates photoprotective agents, antioxidant treatments, skin lighteners, exfoliants, and resurfacing procedures, as needed. Evidence-based studies suggest that first line therapies for melasma encompass intense photoprotection and topical lightening agents.
Many depigmenting agents and other therapies such as chemical peeling are used for treating melasma, in the form of mono or combined therapy .
The most commonly used peeling agents are alpha-hydroxy-acids, glycolic acid, Jessner solution, salicylic acid, trichloroacetic acid (TCA), pyruvic acid and phenol .
Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction. Chemical peelings are used on a wide scale in cosmetic field including melasma treatment. They often provide clinicians with flexibility in tailoring treat- ments according to patient needs and satisfaction.
Chemical peeling is a promising treatment for numerous pigmentary disorders as melasma. It aims to remove the melanin rather than the inhibition of melanocytes or melanogenesis by causing controlled necrosis and subsequent regeneration of the epidermis, apart from remodeling of collagen and elastic fibers in the dermis .
TCA is widely used peeling agent in treatment of hyperpigmentation especially melasma. It is a keratolytic acid which cause precipitation of proteins and coagulation necrosis of the epidermis that leads to reepithelization with replacement of smoother skin with an even skin tone .It is not expensive, stable, not light-sensitive and does not need to be neutralized .
Microdermabrasion (MDA) is a minimally invasive epidermal resurfacing procedure used to treat uneven skin tone/texture, photo aging, striae, melasma, and scars.Microdermabrasion uses a variable flow of vacuum suction to maintain contact with the skin whilst the crystals (or diamond tips) get to work by smoothing and buffing the skin's surface.The crystals (or diamond tips) cause gentle mechanical abrasion to the skin, which ultimately removes the stratum corneum layer of the epidermis. As part of the wound healing process, new epidermis forms with enhanced cosmoses. The technique is considered safe for all Fitzpatrick skin types and complications are minimal. In addition to the cosmetic benefits of MDA, studies have also shown improved skin permeability and enhanced delivery of transdermal medications dosed on an area of the skin treated with MDA. Microdermabrasion removes the stratum corneum, the outermost layer of the epidermis . MDA has also been shown to affect deeper layers of the epidermis and dermis. MDA causes a re-arrangement of melanosomes in the basal layer of the epidermis, flattening of rete ridges at the dermal-epidermal junction, increased collagen fiber density at the dermal-epidermal junction, and vascular ectasia in the reticular dermis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- (Group 1): 30 patients MDA will be done to one half of the face then TCA 15% will be applied to the whole face. (Group 2): 30 patients will receive MDA to one side of the face , TCA 20% will then be applied to the whole face.
| Arm | Type | Receives |
|---|---|---|
| Group 15% concentration | Active comparator | Drug: TCA30 patients MDA will be done to one half of the face then TCA 15% will be applied to the whole face. |
| Group 20 % concentration | Active comparator | Drug: TCA30 patients will receive MDA to one side of the face , TCA 20% will then be applied to the whole face. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults of 18 years and above with bilateral melasma
- Clinical diagnosis of melasma.
- Mental capacity to give informed consent.
Key exclusion criteria (6 listed)
- Pregnant or nursing women
- Current use of hormonal birth control medication or any hormonal therapy
- History of laser or dermabrasion to the face within 9 months of study enrollment
- Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids
- Photosensitivity.
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 |
|---|---|---|
| TCAAlso: MIcrodermabrasion (MDA)All patients will receive 6 sessions at 2 weeks intervals,the half face which will recieve MDA and TCA,MDA will be done before appling TCA. | Drug | Group 15% concentration, Group 20 % concentration |
Primary outcome
"EFFICACY of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma "
Time frame: 3 months
To detect the efficacy of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma. Clinical photographs: Front, right and left views of face of each patient will be photographed at baseline, every two weeks and one month after the last session with and high resolution digital camera in natural light.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 20101327Bandyopadhyay D. Topical treatment of melasma. Indian J Dermatol. 2009;54(4):303-9. doi: 10.4103/0019-5154.57602.
- Background: PubMed 6787100Sanchez NP, Pathak MA, Sato S, Fitzpatrick TB, Sanchez JL, Mihm MC Jr. Melasma: a clinical, light microscopic, ultrastructural, and immunofluorescence study. J Am Acad Dermatol. 1981 Jun;4(6):698-710. doi: 10.1016/s0190-9622(81)70071-9.
- Background: PubMed 20202051Guinot C, Cheffai S, Latreille J, Dhaoui MA, Youssef S, Jaber K, Nageotte O, Doss N. Aggravating factors for melasma: a prospective study in 197 Tunisian patients. J Eur Acad Dermatol Venereol. 2010 Sep;24(9):1060-9. doi: 10.1111/j.1468-3083.2010.03592.x. Epub 2010 Feb 25.
- Background: PubMed 22212073Tamega Ade A, Miot LD, Bonfietti C, Gige TC, Marques ME, Miot HA. Clinical patterns and epidemiological characteristics of facial melasma in Brazilian women. J Eur Acad Dermatol Venereol. 2013 Feb;27(2):151-6. doi: 10.1111/j.1468-3083.2011.04430.x. Epub 2012 Jan 3.
- Background: PubMed 11076368Mandry Pagan R, Sanchez JL. Mandibular melasma. P R Health Sci J. 2000 Sep;19(3):231-4.
- Background: PubMed 22827850Ritter CG, Fiss DV, Borges da Costa JA, de Carvalho RR, Bauermann G, Cestari TF. Extra-facial melasma: clinical, histopathological, and immunohistochemical case-control study. J Eur Acad Dermatol Venereol. 2013 Sep;27(9):1088-94. doi: 10.1111/j.1468-3083.2012.04655.x. Epub 2012 Jul 24.
- BackgroundLapeere H, Boone B, Schepper SD.(2018) : Hypomelanosis and hypermelanosis. In: Wolff K,Goldsmith LA, Katz SI, editors.Dermatology in general medicine. 7th ed. New York: McGraw Hill. p. 635
- BackgroundLebwohl M, Heymann W, Berth-Jones J. Treatment of skin disease: Comprehensive therapeutic strategies. St. Louis, MO: Mosby; 2002.
- Background: PubMed 24679999Molinar VE, Taylor SC, Pandya AG. What's new in objective assessment and treatment of facial hyperpigmentation? Dermatol Clin. 2014 Apr;32(2):123-35. doi: 10.1016/j.det.2013.12.008.
- Background: PubMed 24438951Jutley GS, Rajaratnam R, Halpern J, Salim A, Emmett C. Systematic review of randomized controlled trials on interventions for melasma: an abridged Cochrane review. J Am Acad Dermatol. 2014 Feb;70(2):369-73. doi: 10.1016/j.jaad.2013.07.044.
- Individual participant dataSharing planned: Yes
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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 TCA 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 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: status not confirmed, as of the sponsor's last update on 30 Mar 2021. 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 Hatem Ze mohamed, professor (+201003420217, zedanhzma@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"EFFICACY of combined Trichloroacetic acid (15% or 20 %) and microdermabrasion in treating melasma " (time frame: 3 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 NCT04823520, 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 30 Mar 2021.