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AzTrials

MelasmaPhase 4NCT05099601

Silymarin Cream Versus Combined Silymarin Cream and Microneedling in Treatment of Melasma

A Phase 4 study testing Silymarin and Microneedling in people with Melasma, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Melasma is an acquired pigmentary disorder, occurring most commonly on the face. It is more prevalent in females and darker skin types. Melasma is mainly a clinical diagnosis consisting of symmetric reticulated hypermelanosis in three predominant facial patterns: centrofacial, malar, and mandibular. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Melasma
What is being tested?
Silymarin and Microneedling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
May 2022to Dec 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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age: 18-50 years old.
  • Pattern of melasma: Bilateral symmetrical facial melasma of any pattern.
  • Fitzpatrick skin phototypes: Types III, IV and V

Who cannot join

  • Pregnancy and lactation.
  • Patients taking oral contraceptive pills, hormonal replacement therapy or treatment for chronic illness at the time of the study or during the past 6 months.
  • Coexistance of diseases associated with hyperpigmentation such as Addison disease.
  • Scarring and keloid tendency, active skin infections as active HSV.
  • Previous history of post inflammatory hyperpigmentation.

Trial locations and contacts

No sites are listed yet.

Sahar A Ismail, Professor contact

+201008899446

Saharsotohy@yahoo.com

Rofaida R Shehata, PHD contact

+201006897580

rofaida.refaat@yahoo.com

About this study

Official title: Topical Silymarin Versus Combined Topical Silymarin and Microneedling in Treatment of Melasma: Split Face Study

Melasma is an acquired pigmentary disorder, occurring most commonly on the face. It is more prevalent in females and darker skin types. Melasma is mainly a clinical diagnosis consisting of symmetric reticulated hypermelanosis in three predominant facial patterns: centrofacial, malar, and mandibular. Melasma, though benign, can be extremely psychologically distressing and has been shown to have a significant impact on quality of life, social and emotional wellbeing. Multiple factors are implicated in the pathogenesis of melasma; however, the definite underlying mechanisms are not yet completely established. Ultraviolet exposure is one of the leading etiological factors, besides genetic and hormonal factors.

Read the detailed description

Many studies examined multiple treatment options for melasma, but none of them is completely satisfactory with recurrence in most cases.

Silymarin (SM) is a standardized extract from Silybum marianum seeds, is traditionally used as a hepatoprotective agent for its potent regenerative properties. Lately, SM is utilized in dermatological and cosmetic preparations for its antioxidant effect, anti-inflammatory and immunomodulatory properties.

Silibinin, the main component of silymarin, has been found to have antioxidant properties. It decreases the hazardous effects of solar ultraviolet radiation and significantly prevents melanin production in a dose-dependent manner without effect on cell viability.

Skin microneedling, or percutaneous collagen induction by needles, is a minimally invasive procedure that uses short fine needles to puncture the skin and stimulates fibroblast proliferation, release of growth factors and collagen production.

Long-term improvement of melasma after microneedling was reported , however, the exact mechanism that promotes skin lightening is not known.

Conditions
Melasma
Being tested
Silymarin, Microneedling
Medical subject headings
Melanosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SilymarinCombination product

    The patients will use topical silymarin 0.7% cream on the face twice daily(home use).

  • MicroneedlingProcedure or surgery

    Patients will be subjected to microneedling sessions on one side of the face. Three consecutive sessions, 4 weeks apart (0, 4, 8 weeks), will be performed by dermapen. Sessions will be done by well trained physician.

Study groups in NCT05099601
Study groupRoleWhat they receive
Silymarin alone versus silymarin and microneedlingExperimentalThere will be one group of patients. Each side of the patients' face will be randomly allocated to either topical silymarin 0.7% and microneedling or topical silymarin 0.7% alone.
Receives: Combination Product: Silymarin; Procedure: Microneedling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. compare between the efficacy of topical silymarin alone and its combination with microneedling in treatment of melasma.

    Scoring of the patients according to modified Melasma Area and Severity Index (mMASI) score before and after treatment.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study startMay 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Each side of the patients' face will be randomly allocated to either topical silymarin 0.7% and microneedling or topical silymarin 0.7% alone.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05099601
Sponsor's protocol ID
MSM
Status last verified
Oct 2021
First submitted
2 Oct 2021
Last updated
29 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Balkrishnan R, McMichael AJ, Camacho FT, Saltzberg F, Housman TS, Grummer S, Feldman SR, Chren MM. Development and validation of a health-related quality of life instrument for women with melasma. Br J Dermatol. 2003 Sep;149(3):572-7. doi: 10.1046/j.1365-2133.2003.05419.x.

    PubMed 14510991

  • Choo SJ, Ryoo IJ, Kim YH, Xu GH, Kim WG, Kim KH, Moon SJ, Son ED, Bae K, Yoo ID. Silymarin inhibits melanin synthesis in melanocyte cells. J Pharm Pharmacol. 2009 May;61(5):663-7. doi: 10.1211/jpp/61.05.0016.

    PubMed 19406006

  • Cohen BE, Elbuluk N. Microneedling in skin of color: A review of uses and efficacy. J Am Acad Dermatol. 2016 Feb;74(2):348-55. doi: 10.1016/j.jaad.2015.09.024.

    PubMed 26549251

  • Handel 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

  • Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339. doi: 10.1097/DSS.0000000000000924.

    PubMed 27755171

  • Kimbrough-Green CK, Griffiths CE, Finkel LJ, Hamilton TA, Bulengo-Ransby SM, Ellis CN, Voorhees JJ. Topical retinoic acid (tretinoin) for melasma in black patients. A vehicle-controlled clinical trial. Arch Dermatol. 1994 Jun;130(6):727-33.

    PubMed 8002642

  • Kren V, Walterova D. Silybin and silymarin--new effects and applications. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2005 Jun;149(1):29-41. doi: 10.5507/bp.2005.002.

    PubMed 16170386

  • Nofal A, Ibrahim AM, Nofal E, Gamal N, Osman S. Topical silymarin versus hydroquinone in the treatment of melasma: A comparative study. J Cosmet Dermatol. 2019 Feb;18(1):263-270. doi: 10.1111/jocd.12769. Epub 2018 Aug 26.

    PubMed 30146802

  • Pandya AG, Hynan LS, Bhore R, Riley FC, Guevara IL, Grimes P, Nordlund JJ, Rendon M, Taylor S, Gottschalk RW, Agim NG, Ortonne JP. Reliability assessment and validation of the Melasma Area and Severity Index (MASI) and a new modified MASI scoring method. J Am Acad Dermatol. 2011 Jan;64(1):78-83, 83.e1-2. doi: 10.1016/j.jaad.2009.10.051. Epub 2010 Apr 15.

    PubMed 20398960

  • Rigopoulos D, Gregoriou S, Katsambas A. Hyperpigmentation and melasma. J Cosmet Dermatol. 2007 Sep;6(3):195-202. doi: 10.1111/j.1473-2165.2007.00321.x.

    PubMed 17760699

  • Tamega 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 22212073

  • Tran JM, Chan AW (2012) Quick diagnosis: melasma. University of Toronto Med J 89: 143-145.

  • Vaid M, Katiyar SK. Molecular mechanisms of inhibition of photocarcinogenesis by silymarin, a phytochemical from milk thistle (Silybum marianum L. Gaertn.) (Review). Int J Oncol. 2010 May;36(5):1053-60. doi: 10.3892/ijo_00000586.

    PubMed 20372777

  • Wu DC, Fitzpatrick RE, Goldman MP. Confetti-like Sparing: A Diagnostic Clinical Feature of Melasma. J Clin Aesthet Dermatol. 2016 Feb;9(2):48-57.

    PubMed 27047632

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Silymarin 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 5 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 29 Oct 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 Sahar A Ismail, Professor (+201008899446, Saharsotohy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compare between the efficacy of topical silymarin alone and its combination with microneedling in treatment of 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 NCT05099601, which also lists 14 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 29 Oct 2021.

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