MelasmaNCT03472235
Microneedle and Trichloroaceticacid in Treatment of Melasma
A study testing Microneedle in people with Melasma, run by Assiut University.
Trial summary
Melasma is an acquired disorder of hyperpigmentation characterised by blotchy, light-to-dark brown macules distributed symmetrically on the sun-exposed parts of the body. Although many factors have been proposed to have a role in pathogenesis, the exact ethology is yet to be understood. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Melasma
- What is being tested?
- Microneedle
- 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
- 5 Apr 2018to 5 Apr 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Both sex will be included Age range from 18- 50 yrs.' old Patients with realistic expectations.
Who cannot join
- patients taking oral contraceptive pills. patients with history of polycystic ovary. pregnant and lactating females. patients with active infection. patients on isotretinoin. patients with history of keloids,or hypertrophic scars.
About this study
Official title: Combined Trichlotoaceticacid and Microneedle Versus Trichlroacetic Acid Alone in the Treatment of Melasma
Melasma is an acquired disorder of hyperpigmentation characterised by blotchy, light-to-dark brown macules distributed symmetrically on the sun-exposed parts of the body.
Although many factors have been proposed to have a role in pathogenesis, the exact ethology is yet to be understood. The most commonly identifiable risk factors include ultraviolet radiation, genetic predisposition, pregnancy, oral contraceptives, thyroid disease and drugs like antiepileptic. The excessive pigmentation has been attributed to both melanocytosis (increased number of melanocytes) as well as melano genesis (excess production of melanin) as confirmed in a histopathological study on Asian patients.] Furthermore, a vascular component has also been proposed to play a role in the pathogenesis of melisma. Kim et al. have found that lesion melasma skin had greater expression of the vascular endothelial growth factor in keratinocytes compared to nearby nonlesional skin.
Read the detailed description
As regards management, the therapeutic options range from photoprotection, topical hypopigmenting agents, chemical peels and lasers. There are variety of less-tried systemic agents like fish oil, green tea and . Although no single agent has proved to be effective for all patients, a combination of two or three agents is often tried to achieve optimum results.
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 the regeneration of new epidermal and dermal tissues.
Chemical peels are a well-known modality of treatment for melasma. The basic mechanism of the action of chemical peels in melasma is the removal of unwanted melanin by causing a controlled chemical burn to the skin.
Trichlroacetic acid peeling has been the gold standard in chemical peeling for many decades.
For superficial peels Trichlroacetic acid 10% to 25% are used. some authors consider up to 35% Trichlroacetic acid as also a superficial.
Skin microneedling is a technique predominantly used to improve the appearance of cutaneous scarring and photo damage.
Fine needles puncture the skin, resulting in increased dermal elastin and collagen, collagen remodelling, and thickening of the epidermis and dermis. Additionally, skin needling creates small channels, which increase the absorption of topically applied preparations A property which has been used in various dermatological treatments.
- Conditions
- Melasma
- Being tested
- Microneedle
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedleDevice
TCA peeling session: Facial skin will be cleansed with tap water and degreased by rubbing with an alcohol sponge .
Then TCA 25% will be applied to the whole face by cotton tipped applicator or gauze pad. The entire face will be treated until complete frosting occur.
The patients will be instructed to wash their faces to decrease the burning sensation.
Combined session: starts with microneedle using microneedle device (Derma pen) The skin of each patient is cleaned with anti septic solution and anesthetic cream may be applied to lessen discomfort.
(Dermapen) will be applied on the lesional skin in four direction, vertical, horizontal and in the two diagonal until pin point bleeding occur which will be gently massaged .
After 10 minutes TCA peeling will be applied TCA peeling will be done for 8 session with 2 weeks interval between each session.
Microneedle will be done for 4session with 4 weeks interval between each session.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | include 20 patients will be treated with TCA25% +microneedle 8 sessions for TCA 25 peel and 4 sessions for microneedle (derma pen). Receives: Device: Microneedle |
| B | Active comparator | include 20 patient will be treated with TCA 25% only ( 8 sessions) Receives: Device: Microneedle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring of the patients according to modified melasma are abd severity index [mMASI] Scoring before and After last session will be done by 1 month
Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100.
Clinical efficacy was categorized into :
Excellent response: if morethan 75%fall in [mMASI] score. Very good response:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in [mMASI] score at the end of the therapy.
Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100.
Clinical efficacy was categorized into :
Excellent response: if morethan 75%fall in [mMASI] score. Very goodresponse:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in [mMASI] score at the end of the therapy.
Measured: 1 month after last session
[mMASI] Scoring before and After last session will be done by 3 months
before x100.
Clinical efficacy was categorized into :
Excellent response: if morethan 75%fall in [mMASI] score. Very good response:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in [mMASI] score at the end of the therapy.
Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100.
Clinical efficacy was categorized into :
Excellent response: if morethan 75%fall in [mMASI] score. Very goodresponse:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no c
Measured: 3 months after last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start5 Apr 2018 (estimated)
- Primary completion5 Apr 2019 (estimated)
- Study completion5 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TCA peeling session: Facial skin will be cleansed with tap water and degreased by rubbing with an alcohol sponge . Then TCA 25% will be applied to the whole face by cotton tipped applicator or gauze pad. The entire face will be treated until complete frosting occur. The patients will be instructed to wash their faces to decrease the burning sensation. Combined session: starts with microneedling using microneedling device (Dermapen) The skin of each patient is cleaned with anti septic solution and anesthetic cream may be applied to lessen discomfort. (Dermapen) will be applied on the lesional skin in four direction, vertical, horizontal and in the two diagonal until pin point bleeding occur which will be gently massaged . After 10 minutes TCA peeling will be applied TCA peeling will be done for 8 session with 2 weeks interval between each session. Microneedling will be done for 4session with 4 weeks interval between each session.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472235
- Sponsor's protocol ID
- MTTM
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2018
- Last updated
- 21 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sheth 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 21920242
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Trichlotoaceticacid and Microneedle Versus Trichlroacetic Acid Alone in the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT03472235
- Acronym / sponsor ID
- MTTM
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Apr 2018 (estimated)
- Primary completion
- 5 Apr 2019 (estimated)
- Study completion
- 5 Apr 2020 (estimated)
- First posted
- 21 Mar 2018 (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 disorder of hyperpigmentation characterised by blotchy, light-to-dark brown macules distributed symmetrically on the sun-exposed parts of the body.
Although many factors have been proposed to have a role in pathogenesis, the exact ethology is yet to be understood. The most commonly identifiable risk factors include ultraviolet radiation, genetic predisposition, pregnancy, oral contraceptives, thyroid disease and drugs like antiepileptic. The excessive pigmentation has been attributed to both melanocytosis (increased number of melanocytes) as well as melano genesis (excess production of melanin) as confirmed in a histopathological study on Asian patients.] Furthermore, a vascular component has also been proposed to play a role in the pathogenesis of melisma. Kim et al. have found that lesion melasma skin had greater expression of the vascular endothelial growth factor in keratinocytes compared to nearby nonlesional skin.
Detailed description
As regards management, the therapeutic options range from photoprotection, topical hypopigmenting agents, chemical peels and lasers. There are variety of less-tried systemic agents like fish oil, green tea and . Although no single agent has proved to be effective for all patients, a combination of two or three agents is often tried to achieve optimum results.
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 the regeneration of new epidermal and dermal tissues.
Chemical peels are a well-known modality of treatment for melasma. The basic mechanism of the action of chemical peels in melasma is the removal of unwanted melanin by causing a controlled chemical burn to the skin.
Trichlroacetic acid peeling has been the gold standard in chemical peeling for many decades.
For superficial peels Trichlroacetic acid 10% to 25% are used. some authors consider up to 35% Trichlroacetic acid as also a superficial.
Skin microneedling is a technique predominantly used to improve the appearance of cutaneous scarring and photo damage.
Fine needles puncture the skin, resulting in increased dermal elastin and collagen, collagen remodelling, and thickening of the epidermis and dermis. Additionally, skin needling creates small channels, which increase the absorption of topically applied preparations A property which has been used in various dermatological treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- TCA peeling session: Facial skin will be cleansed with tap water and degreased by rubbing with an alcohol sponge . Then TCA 25% will be applied to the whole face by cotton tipped applicator or gauze pad. The entire face will be treated until complete frosting occur. The patients will be instructed to wash their faces to decrease the burning sensation. Combined session: starts with microneedling using microneedling device (Dermapen) The skin of each patient is cleaned with anti septic solution and anesthetic cream may be applied to lessen discomfort. (Dermapen) will be applied on the lesional skin in four direction, vertical, horizontal and in the two diagonal until pin point bleeding occur which will be gently massaged . After 10 minutes TCA peeling will be applied TCA peeling will be done for 8 session with 2 weeks interval between each session. Microneedling will be done for 4session with 4 weeks interval between each session.
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Microneedleinclude 20 patients will be treated with TCA25% +microneedle 8 sessions for TCA 25 peel and 4 sessions for microneedle (derma pen). |
| B | Active comparator | Device: Microneedleinclude 20 patient will be treated with TCA 25% only ( 8 sessions) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Both sex will be included Age range from 18- 50 yrs.' old Patients with realistic expectations.
Key exclusion criteria (1 listed)
- patients taking oral contraceptive pills. patients with history of polycystic ovary. pregnant and lactating females. patients with active infection. patients on isotretinoin. patients with history of keloids,or hypertrophic scars.
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 |
|---|---|---|
| MicroneedleTCA peeling session: Facial skin will be cleansed with tap water and degreased by rubbing with an alcohol sponge . Then TCA 25% will be applied to the whole face by cotton tipped applicator or gauze pad. The entire face will be treated until complete frosting occur. The patients will be instructed to wash their faces to decrease the burning sensation. Combined session: starts with microneedle using microneedle device (Derma pen) The skin of each patient is cleaned with anti septic solution and anesthetic cream may be applied to lessen discomfort. (Dermapen) will be applied on the lesional skin in four direction, vertical, horizontal and in the two diagonal until pin point bleeding occur which will be gently massaged . After 10 minutes TCA peeling will be applied TCA peeling will be done for 8 session with 2 weeks interval between each session. Microneedle will be done for 4session with 4 weeks interval between each session. | Device | A, B |
Primary outcome
Scoring of the patients according to modified melasma are abd severity index [mMASI] Scoring before and After last session will be done by 1 month
Time frame: 1 month after last session
Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in [mMASI] score. Very good response:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in [mMASI] score at the end of the therapy. Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in [mMASI] score. Very goodresponse:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in [mMASI] score at the end of the therapy.
[mMASI] Scoring before and After last session will be done by 3 months
Time frame: 3 months after last session
before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in [mMASI] score. Very good response:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in [mMASI] score at the end of the therapy. Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in [mMASI] score. Very goodresponse:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no c
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- 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.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedle 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 1 inclusion and 1 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 21 Mar 2018. 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.
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?
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?
Scoring of the patients according to modified melasma are abd severity index [mMASI] Scoring before and After last session will be done by 1 month (time frame: 1 month after last session). The study lists 2 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 NCT03472235, which also lists 1 linked publication.
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 21 Mar 2018.