MelasmaNCT05326997
Treatment of Melasma With Yellow Light Compared to Tranexamic Acid
A study testing Photobiomodulation group in people with Melasma, run by University of Nove de Julho at 2 sites in Brazil.
Trial summary
Photobiomodulation (PBM) has been suggested as an alternative treatment for Melasma, showed by the in vitro data, inhibition of the tyrosinase enzyme and reduction in the pigment content by autophagy. This treatment compares with tranexamic acid, where it acts on similar pathways of melanogenesis. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Melasma
- What is being tested?
- Photobiomodulation group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 May 2023to 30 Oct 2023
- 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 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Feminine gender
- Age between 35 to 50 years
- Phototypes l to lV of the Fitzpatrick scale
- Facial melasma
- Healthy participants without clinical skin comorbidities (psoriasis, vitiligo, rosacea and dermatoses)
Who cannot join
- Pre-existing systemic diseases, autoimmune diseases, digestive system disease
- Polycystic ovary
- Isotretinoin drug use (less than 6 months)
- Sequelae of an accident on the face that interferes with the facial treatment
- Undertakes any treatment for topical or oral Melasma at the time of the research or less than 3 months ago
- Uses retinoic acid, vitamin A derivatives, photosensitizing drugs
Show all 13Show fewer
- Skin pathologies on the face
- Glaucoma, cataract, cancer patients, pregnant women, lactating women
- Uses oral or intrauterine contraceptives (IUD)
- Thyroid disorders
- Use of hormone replacement
- Bacterial, viral and fungal infections
- Tendency to form keloids
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Galache Clinic
São Caetano do Sul, São Paulo, 09550050
Universidade Nove de Julho
São Paulo, 01504001
About this study
Official title: Photobiomodulation With Yellow Light in the Treatment of Melasma: Clinical Trial, Randomized, Controlled, Double Blind.
Photobiomodulation (PBM) has been suggested as an alternative treatment for Melasma, showed by the in vitro data, inhibition of the tyrosinase enzyme and reduction in the pigment content by autophagy. This treatment compares with tranexamic acid, where it acts on similar pathways of melanogenesis. A total of 54 female participants, phototype scale Fitzpatrick ll - lV will be recruited which will be distributed among two groups: Light + placebo Home Care cosmetic product and Light sham + Home Care cosmetic product with tranexamic acid. The treatments will consist of 90 days, with application of photobiomodulation (PBM) once a week and application of the cosmetic product twice a day.
Read the detailed description
This is a controled, randomized, double blind, two arms clinical trial. The main objective of this study is to evaluate the effect of photobiomodulation with amber light in the treatment of Melasma compared to the effect of tranexamic acid. The sample will be divided into 2 groups: Group 1 will receive PBM with amber Light Emitting Diode (LED) (DMC E-Light ABR), 20 J/cm² and placebo topical cosmetic for use in home care; Group 2 will receive PBM sham and topical cosmetic containing 5% liposomal tranexamic acid for use in home care. A total of 54 women with facial Melasma, aged 35 to 50 will be included. The treatments will consist of 12 sessions, once a week for 3 months. The severity of Melasma will be evaluated through the Melasma Area and Severity Index (MASI index), the pigmentation of the epidermis will be evaluated by corneomelametry, photographic records and the quality of life questionnaire (MELASQoL-PB) will also be made.
- Conditions
- Melasma
- Being tested
- Photobiomodulation group, Group control (Tranexamic acid)
- Keywords
- Low Level Laser Therapy (LLLT), Melasma, Photobiomodulation, Tranexamic Acid
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation groupDevice
Participants will have their face sanitized with micellar water (a cosmetic product for cleaning and makeup remover), followed by cleaning with soap. Then, the eyes will be protected with gauze, proper glasses and a black towel on top, a headset with relaxation music will also be placed and then the face will receive the treatment with yellow light. After the session the face will receive sunscreen. A placebo cosmetic will be given to the participant to be applied twice a day and daily sunscreen.
Group control (Tranexamic acid)Other
Participants will have their face sanitized with micellar water. Then, the eyes will be protected with gauze, proper glasses and a black towel on top, a headset with relaxation music will also be placed and then the face will receive the treatment with yellow light sham. The person responsible for applying the PBM will simulate the irradiations by positioning the device in the same places described for the PBM group, however, the equipment will be kept off. After the session the face will receive sunscreen. Will be delivered to patients, liposomal tranexamic acid with use 2 x a day home care and daily sunscreen.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation (PBM) with placebo cosmetic treatment. | Experimental | Participants will receive the intervention with PBM using amber light (DMC E-Light ABR), 20 J/cm² and will also receive a product for daily home topical use containing only the cosmetic base without active. Receives: Device: Photobiomodulation group |
| Photobiomodulation (PBM) sham with 5% liposomal tranexamic acid cosmetic product | Active comparator | Participants will receive the simulated intervention with PBM using amber light (DMC E-Light ABR) and will also receive a product for topical home use containing 5% liposomal tranexamic acid. Receives: Other: Group control (Tranexamic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MASI (Melasma Area and Severity Index)
Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores
Measured: Before treatment (week 0).
MASI (Melasma Area and Severity Index)
Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores
Measured: Half treatment (Week 6)
MASI (Melasma Area and Severity Index)
Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores
Measured: After the treatments (week 12).
Secondary outcomes (5)
Corneomelametry
Quantifies the melanin present in the epidermis, specifically in the stratum corneum. A direct sample of the participant's skin will be collected with cyanoacrylate strippings (CSSS)
Measured: Before (week 0), at half (week 6) and after treatment (week 12).
Photography
Registry of photographs at white and wood lamp
Measured: Before (week 0), at half (week 6) and after treatment (week 12).
Final global diagnosis of the skin.
Clinical subjective measure with the aid of photographic records, in relation to the change by the severity of Melasma of pigmentation after treatment
Measured: Before (week 0), at half (week 6) and after treatment (week 12).
The MELASQoL questionnaire, (Melasma Quality of Life Scale)
Evaluates the impact of Melasma on the quality of life of those affected by the disease and will be applied with the aim of evaluating facial self-image and their degree of satisfaction.
Measured: Before (week 0), at half (week 6) and after treatment (week 12).
Adverse Effects
Registry of any discomfort or unexpected effect of the treatment
Measured: At half (week 6) and after treatment (week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 May 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Why it stopped: Due to implementation challenges, we categorized this study as a pilot and ended data collection, intending to adapt methods for future trials. Although the initial sample size was 54, data from 21 participants were analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies of the same condition, open and under way.
- 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
- All participants will receive a skin preparation with enzymatic peeling, for homogeneity in the thickness of the stratum corneum among the participants and to reduce the unwanted reflection of photons. One week after the application of the peeling, the pre-treatment evaluation will be carried out and the participants will receive the intervention related to their treatment group, according to the allocation given by randomization. The area to be treated will be sanitized with Rennova® Beauté Micellar Water for makeup/sunscreen removal. Then, a cleaning foam based on 10% urea from Vivence laboratory will be used and also removed with gauze. After randomization, the study population will be divided into two groups (n=28 per group), wich are: (1) Group A - PBM with yellow LED application + placebo cosmetic treatment Home Care 2x per day, (2) Group B - PBM sham + treatment with 5% liposomal tranexamic acid Home Care cosmetic cream 2x per day.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Pavani, University of Nove de Julho
- Investigators
- Thais Rodrigues Galache, MSc Fellow, Study chair, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326997
- Sponsor's protocol ID
- TRG
- Status last verified
- Oct 2024
- First submitted
- 8 Apr 2022
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Researchers who provide a methodologically sound proposal will have access. Proposals should be directed to chrispavani@gmail.com To gain access, data requestors will need to sign a data access agreement.
Publications
Galache TR, Galache M, Barros RTB, Bezerra CDDS, Sena MM, Pavani C. Amber LED photobiomodulation versus tranexamic acid for the treatment of melasma: randomized controlled double-blind pilot trial. Lasers Med Sci. 2025 Jul 12;40(1):313. doi: 10.1007/s10103-025-04567-9.
PubMed 40650752Galache TR, Galache M, Sena MM, Pavani C. Amber photobiomodulation versus tranexamic acid for the treatment of melasma: protocol for a double-blind, randomised controlled trial. BMJ Open. 2023 Jul 21;13(7):e073568. doi: 10.1136/bmjopen-2023-073568.
PubMed 37479524
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation With Yellow Light in the Treatment of Melasma: Clinical Trial, Randomized, Controlled, Double Blind.
- ClinicalTrials.gov ID
- NCT05326997
- Acronym / sponsor ID
- TRG
- Conditions
- Melasma
- Keywords
- Low Level Laser Therapy (LLLT), Melasma, Photobiomodulation, Tranexamic Acid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to implementation challenges, we categorized this study as a pilot and ended data collection, intending to adapt methods for future trials. Although the initial sample size was 54, data from 21 participants were analyzed.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 14 Apr 2022 (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.
Photobiomodulation (PBM) has been suggested as an alternative treatment for Melasma, showed by the in vitro data, inhibition of the tyrosinase enzyme and reduction in the pigment content by autophagy. This treatment compares with tranexamic acid, where it acts on similar pathways of melanogenesis. A total of 54 female participants, phototype scale Fitzpatrick ll - lV will be recruited which will be distributed among two groups: Light + placebo Home Care cosmetic product and Light sham + Home Care cosmetic product with tranexamic acid. The treatments will consist of 90 days, with application of photobiomodulation (PBM) once a week and application of the cosmetic product twice a day.
Detailed description
This is a controled, randomized, double blind, two arms clinical trial. The main objective of this study is to evaluate the effect of photobiomodulation with amber light in the treatment of Melasma compared to the effect of tranexamic acid. The sample will be divided into 2 groups: Group 1 will receive PBM with amber Light Emitting Diode (LED) (DMC E-Light ABR), 20 J/cm² and placebo topical cosmetic for use in home care; Group 2 will receive PBM sham and topical cosmetic containing 5% liposomal tranexamic acid for use in home care. A total of 54 women with facial Melasma, aged 35 to 50 will be included. The treatments will consist of 12 sessions, once a week for 3 months. The severity of Melasma will be evaluated through the Melasma Area and Severity Index (MASI index), the pigmentation of the epidermis will be evaluated by corneomelametry, photographic records and the quality of life questionnaire (MELASQoL-PB) will also be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive a skin preparation with enzymatic peeling, for homogeneity in the thickness of the stratum corneum among the participants and to reduce the unwanted reflection of photons. One week after the application of the peeling, the pre-treatment evaluation will be carried out and the participants will receive the intervention related to their treatment group, according to the allocation given by randomization. The area to be treated will be sanitized with Rennova® Beauté Micellar Water for makeup/sunscreen removal. Then, a cleaning foam based on 10% urea from Vivence laboratory will be used and also removed with gauze. After randomization, the study population will be divided into two groups (n=28 per group), wich are: (1) Group A - PBM with yellow LED application + placebo cosmetic treatment Home Care 2x per day, (2) Group B - PBM sham + treatment with 5% liposomal tranexamic acid Home Care cosmetic cream 2x per day.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation (PBM) with placebo cosmetic treatment. | Experimental | Device: Photobiomodulation groupParticipants will receive the intervention with PBM using amber light (DMC E-Light ABR), 20 J/cm² and will also receive a product for daily home topical use containing only the cosmetic base without active. |
| Photobiomodulation (PBM) sham with 5% liposomal tranexamic acid cosmetic product | Active comparator | Other: Group control (Tranexamic acid)Participants will receive the simulated intervention with PBM using amber light (DMC E-Light ABR) and will also receive a product for topical home use containing 5% liposomal tranexamic acid. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Feminine gender
- Age between 35 to 50 years
- Phototypes l to lV of the Fitzpatrick scale
- Facial melasma
- Healthy participants without clinical skin comorbidities (psoriasis, vitiligo, rosacea and dermatoses)
Key exclusion criteria (13 listed)
- Pre-existing systemic diseases, autoimmune diseases, digestive system disease
- Polycystic ovary
- Isotretinoin drug use (less than 6 months)
- Sequelae of an accident on the face that interferes with the facial treatment
- Undertakes any treatment for topical or oral Melasma at the time of the research or less than 3 months ago
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 |
|---|---|---|
| Photobiomodulation groupParticipants will have their face sanitized with micellar water (a cosmetic product for cleaning and makeup remover), followed by cleaning with soap. Then, the eyes will be protected with gauze, proper glasses and a black towel on top, a headset with relaxation music will also be placed and then the face will receive the treatment with yellow light. After the session the face will receive sunscreen. A placebo cosmetic will be given to the participant to be applied twice a day and daily sunscreen. | Device | Photobiomodulation (PBM) with placebo cosmetic treatment. |
| Group control (Tranexamic acid)Participants will have their face sanitized with micellar water. Then, the eyes will be protected with gauze, proper glasses and a black towel on top, a headset with relaxation music will also be placed and then the face will receive the treatment with yellow light sham. The person responsible for applying the PBM will simulate the irradiations by positioning the device in the same places described for the PBM group, however, the equipment will be kept off. After the session the face will receive sunscreen. Will be delivered to patients, liposomal tranexamic acid with use 2 x a day home care and daily sunscreen. | Other | Photobiomodulation (PBM) sham with 5% liposomal tranexamic acid cosmetic product |
Primary outcome
MASI (Melasma Area and Severity Index)
Time frame: Before treatment (week 0).
Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores
MASI (Melasma Area and Severity Index)
Time frame: Half treatment (Week 6)
Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores
MASI (Melasma Area and Severity Index)
Time frame: After the treatments (week 12).
Determines the affected area and the severity of Melasma, through visual analysis of the affected site and attribution of scores
5 secondary outcomes
Corneomelametry
Time frame: Before (week 0), at half (week 6) and after treatment (week 12).
Photography
Time frame: Before (week 0), at half (week 6) and after treatment (week 12).
Final global diagnosis of the skin.
Time frame: Before (week 0), at half (week 6) and after treatment (week 12).
The MELASQoL questionnaire, (Melasma Quality of Life Scale)
Time frame: Before (week 0), at half (week 6) and after treatment (week 12).
Adverse Effects
Time frame: At half (week 6) and after treatment (week 12).
Results and safety
The study was stopped early (reason given: Due to implementation challenges, we categorized this study as a pilot and ended data collection, intending to adapt methods for future trials. Although the initial sample size was 54, data from 21 participants were analyzed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Derived from this study: PubMed 40650752Galache TR, Galache M, Barros RTB, Bezerra CDDS, Sena MM, Pavani C. Amber LED photobiomodulation versus tranexamic acid for the treatment of melasma: randomized controlled double-blind pilot trial. Lasers Med Sci. 2025 Jul 12;40(1):313. doi: 10.1007/s10103-025-04567-9.
- Derived from this study: PubMed 37479524Galache TR, Galache M, Sena MM, Pavani C. Amber photobiomodulation versus tranexamic acid for the treatment of melasma: protocol for a double-blind, randomised controlled trial. BMJ Open. 2023 Jul 21;13(7):e073568. doi: 10.1136/bmjopen-2023-073568.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Researchers who provide a methodologically sound proposal will have access. Proposals should be directed to chrispavani@gmail.com To gain access, data requestors will need to sign a data access agreement.
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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.
Thais Rodrigues Galache, MSc Fellow study chair
University of Nove de Julho
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation group in people with Melasma, run by University of Nove de Julho at 2 sites in Brazil.
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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
The study was stopped early (reason given: Due to implementation challenges, we categorized this study as a pilot and ended data collection, intending to adapt methods for future trials. Although the initial sample size was 54, data from 21 participants were analyzed.). 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?
MASI (Melasma Area and Severity Index) (time frame: Before treatment (week 0).). The study lists 3 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 NCT05326997, which also lists 2 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 21 Oct 2024.