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MelasmaNCT07060157

Comparative Efficacy of Resveratrol 1 % Gel and Trichloroacetic Acid 20% in Treatment of Melasma: A Split-face Study

A study testing resveratrol 1 % gel and TCA20% in people with Melasma, run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

1. To evaluate the efficacy and safety of topical resveratrol 1 % gel in treatment of melasma. 2. To compare between the efficacy of topical resveratrol 1 %gel versrs chemical peeling with TCA 20% in melasma. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Melasma
What is being tested?
resveratrol 1 % gel and TCA20%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteEgypt
Study dates
22 Jul 2025to 8 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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.
  • Coexistence of diseases associated with hyperpigmentation such as Addison disease.
  • History of Scarring and keloid tendency
  • Active skin infections as active HSV.
  • Previous history of post- inflammatory hyperpigmentation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

amira mohamed bakry, Resident doctor of Dermatology contact

+201014524304 ext. +201050007566

amirakedwany@icloud.com

Dalia Abdel-Aziz Ahmed Attallah, Professor of Dermatology contact

+201005677229

daliaattallah@aun.edu.eg

Egypt1 site
  • Assuit

    Asyut

Other trials in Egypt

About this study

  1. To evaluate the efficacy and safety of topical resveratrol 1 % gel in treatment of melasma.
  2. To compare between the efficacy of topical resveratrol 1 %gel versrs chemical peeling with TCA 20% in melasma.
Read the detailed description

Melasma is a chronic, acquired disorder of focal hypermelanosis. It clinically presents as hyperpigmented patches over photo-exposed areas (Espósito.,et al 2022). Melasma classified clinically into; Centrofacial, malar, mandibular, indeterminate , and extrafacial types . By wood's lamp ,melasma classified into epidermal, dermal, and mixed forms (Putra Gofur N et al . , 2021) .

Chronic ultraviolet (UV) exposure, genetic factors, and sex hormones are generally believed to be involved in the occurrence of melasma. Other factors implicated are phototoxic drugs, anticonvulsant medications, and the use of certain cosmetics (Ortonne et al., 2009).

Treating melasma is challenging especially in patients with dark skin types , classified as Fitzpatrick types IV to VI, due to the possibility of relapse and susceptibility to post-inflammatory hyperpigmentation (PIH) (Rodrigues and Pandya., 2015).

Although various therapeutic approaches including pharmacological and procedural treatments have been considered in melasma management, none of them is completely satisfactory (Rodrigues and Pandya., 2015).

Ongoing clinical trials continue to explore new topical treatment options for melasma, aiming to develop more effective and safer alternatives with fewer side effects. Traditional agents like hydroquinone remain the gold standard, but concerns over irritation and potential long-term risks have driven research into novel formulations. (Christian and Michelle.,2024) .

Resveratrol is a natural phenolic compound present in wide variety of foods, such as grapes, blueberries and peanuts . It has shown many bioactivities, such as antioxidant, anti-inflammatory, immunomodulatory and anticancer agent (Athar M., 2009).

Resveratrol a direct tyrosinase inhibitor by it is ability to bind to the active site of tyrosinase and interfere with its ability to catalyze the conversion of tyrosine to melanin. This could be achieved by interacting with the copper ions present at the enzyme's active site, which are critical for its enzymatic function. Resveratrol has also an indirect inhibitor by modulation the expression of genes involved in melanin synthesis. It has been shown to affect various signaling pathways, including those related to the melanogenesis process, such as the MITF (microphthalmia-associated transcription factor) pathway. By downregulating these pathways, resveratrol can reduce the production of tyrosinase, thus decreasing melanin synthesis. Furthermore, it can affect keratinocytes, which regulate the function of melanocyte (Newton et al., 2007).

Resveratrol regulates the inflammatory process of keratinocytes and protects them from oxidative damage. In this way, it prevents keratinocyte-induced melanocyte stimulation. Furthermore, it has a rescuing effect on the stemness of interfollicular epidermal cells that can repair signs of photoaging in the melasma (Na J et al., 2019).

Chmical peels are an attractive treatment option for patients, as they are an affordable in-office procedure, quick in achieving results, and the patient can return to daily activities immediately after the procedure (Rendon et al., 2010).

Chemical peels are typically categorized based on their depth of skin penetration, which can range from light to medium to deep. Several factors, including pH and concentration, application technique, and the patient's skin condition and sensitivity, influence the extent of the therapeutic effects (O'Connor A A .,et al 2018).

Trichloroacetic Acid (TCA) is a versatile peeling agent, since the peel depth can be varied according to the concentration of TCA solution used. It is commonly used as a superficial to medium depth peel with advantages of being stable, inexpensive, self-neutralizing and without any systemic toxicity (Rubin MG et al., 2018)

Conditions
Melasma
Being tested
resveratrol 1 % gel, TCA20%
Keywords
resveratrol in melasma
Medical subject headings
Melanosis

What participants receive

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

  • resveratrol 1 % gelDrug

    Also called 1

    left side of face the patient will be given resveratrol 1 % gel once daily at night (Home use ).

  • TCA20%Drug

    left side of face the patient will be given resveratrol 1 % gel once daily at night (homThee use ).

Study groups in NCT07060157
Study groupRoleWhat they receive
Group AActive comparatorleft side of face the patient will be given resveratrol 1 % gel once daily at night (homThee use ).
Receives: Drug: resveratrol 1 % gel
Group BActive comparatorThe right side of face will treated with TCA20% every two weeks for 3months.
Receives: Drug: TCA20%

What is being measured

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

  1. The primary outcome is the change in hemi-Melasma Area and Severity Index (hemi-MASI) score from baseline to one month after the end of treatment (follow-up)

    assessed by clinical evaluation and photographic documentation. Clinical efficacy will be categorized as:

    Excellent response: >75% decrease in hemi-MASI score

    Very good response: 50-75% decrease in hemi-MASI score

    Good response: 25-50% decrease in hemi-MASI score

    Poor response: <25% decrease in hemi-MASI score

    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 posted11 Jul 2025
  2. Study start22 Jul 2025 (estimated)
  3. Primary completion8 Aug 2026 (estimated)
  4. Study completion8 Jun 2027 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07060157
Sponsor's protocol ID
resveratrol in melasma
Status last verified
Jul 2025
First submitted
21 Mar 2025
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing resveratrol 1 % gel and TCA20% in people with Melasma, run by Assiut University at 1 site in Egypt.

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: opening soon, as of the sponsor's last update on 11 Jul 2025. 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 Egypt. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact amira mohamed bakry, Resident doctor of Dermatology (+201014524304 ext. +201050007566, amirakedwany@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome is the change in hemi-Melasma Area and Severity Index (hemi-MASI) score from baseline to one month after the end of treatment (follow-up) (time frame: 3 months). 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 11 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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