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.
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
Dalia Abdel-Aziz Ahmed Attallah, Professor of Dermatology contact
About this study
- To evaluate the efficacy and safety of topical resveratrol 1 % gel in treatment of melasma.
- 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 group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | left side of face the patient will be given resveratrol 1 % gel once daily at night (homThee use ). Receives: Drug: resveratrol 1 % gel |
| Group B | Active comparator | The 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.
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.
- First posted11 Jul 2025
- Study start22 Jul 2025 (estimated)
- Primary completion8 Aug 2026 (estimated)
- Study completion8 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohamed Bakry Refaay, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Resveratrol 1 % Gel and Trichloroacetic Acid 20% in Treatment of Melasma: A Split-face Study
- ClinicalTrials.gov ID
- NCT07060157
- Acronym / sponsor ID
- resveratrol in melasma
- Conditions
- Melasma
- Keywords
- resveratrol in melasma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 22 Jul 2025 (estimated)
- Primary completion
- 8 Aug 2026 (estimated)
- Study completion
- 8 Jun 2027 (estimated)
- First posted
- 11 Jul 2025 (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 evaluate the efficacy and safety of topical resveratrol 1 % gel in treatment of melasma.
- To compare between the efficacy of topical resveratrol 1 %gel versrs chemical peeling with TCA 20% in melasma.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: resveratrol 1 % gelleft side of face the patient will be given resveratrol 1 % gel once daily at night (homThee use ). |
| Group B | Active comparator | Drug: TCA20%The right side of face will treated with TCA20% every two weeks for 3months. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Age: 18-50 years old.
Key exclusion criteria (6 listed)
- Pregnancy and lactation.
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 |
|---|---|---|
| resveratrol 1 % gelAlso: 1left side of face the patient will be given resveratrol 1 % gel once daily at night (Home use ). | Drug | Group A |
| TCA20%left side of face the patient will be given resveratrol 1 % gel once daily at night (homThee use ). | Drug | Group B |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Yes
Related trials for Melasma
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COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA
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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.
amira mohamed bakry, Resident doctor of Dermatology contact
Dalia Abdel-Aziz Ahmed Attallah, Professor of Dermatology contact
1 site in 1 country: see every site and its status.
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.