MelasmaNCT06174545
Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma
A study testing Pigment Solution Program in people with Melasma, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
Trial summary
This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in multicenters at two Dermatology and Venereology Education centers in Indonesia. This study aims to determine the effectiveness and safety of PSP as adjuvant therapy for melasma. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Pigment Solution Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Sep 2023to 31 Dec 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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women aged 30-60 years
- Fitzpatrick skin phototype IV-V
- Diagnosis of epidermal, mixed and dermal types of Melasma
Who cannot join
- Are pregnant or breastfeeding
- Use other lightening agents, both oral and topical
- Allergy to PSP content
- Use of other topical therapies for skin disorders may interfere with the evaluation of melasma conditions
- Suffering from other skin diseases such as acne, dermatitis
- Using hormonal birth control
Trial locations and contacts
1 site in 1 country.
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang contact
Indonesia1 site, 1 recruiting
- Recruiting
Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang, 62818130761, irma_bernadette@yahoo.com
dr. Lilik Norawat, Sp.KK, FINSDV Norawati, 628121107149, liliknora21@gmail.com
About this study
This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in multicenters at two Dermatology and Venereology Education centers in Indonesia.
This study aims to determine the effectiveness and safety of PSP as adjuvant therapy for melasma.
This research will be attended by 33 research subjects
Read the detailed description
Melasma is one of the most common hyperpigmentary dermatoses, found mostly in Asian or Hispanic people living in tropical areas.
The goal of melasma treatment is to remove existing pigmentation and to inhibit pigmentation. Until now, hydroquinone (HQ) is still used as the Gold Standard for melasma therapy.
Various epidemiological studies calculate the prevalence of melasma, it is estimated that the prevalence of melasma is 1% in the general population and in high risk populations it is 9 - 50%. This large variation is due to differences in skin type, ethnicity, and level of UV exposure
The diagnosis of melasma is based on the clinical picture, namely light to dark brown macules with irregular edges and a distribution that tends to be symmetrical, especially on the face. Supporting examinations can be carried out to determine the degree of melasma and monitor the therapy given.
This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in multicenters at two Dermatology and Venereology Education centers in Indonesia. The number of samples was 33 divided into 2 groups based on consecutive sampling to obtain subjects who met the eligibility criteria. Then subjects will be allocated into two groups using block randomization.
What is meant by group 1 is control, getting SPF 30 sunscreen cream in the morning and only 2% Hydroquinone cream at night without a combination cream and facial soap that can be used in the morning and evening. Meanwhile, group 2, the treatment group, used PSP cleanser, PSP Day Cream and SPF 30 sunscreen in the morning and used Hydroquinone 2% and PSP Night Cream at night and PSP cleanser which was used in the morning and evening before using the cream.
Data collection and research will be carried out for 3 months and data management and analysis will be carried out for the following 1 month. Follow up will be carried out at Week 4, Week 8 and Week 12. Each follow up will be analyzed as follows:
- Physical examination
- 5 position face photos
- Mexameter examination
- Dermoscopic examination
- Check wood lamp
- MelasQoL check
- Calculation of mMASI Score
- Completing the Investigator's Global Assessment questionnaire
- Completing the Patient's Global Assessment Questionnaire
- Completing the Investigator's Tolerability Assessment questionnaire
Data is recorded in research status which is then compiled into a master table. After recording the research results is complete, the masking code is opened for statistical analysis. Data analysis used statistical tests in accordance with the intention to treat approach with research subject analysis methods based on intervention groups. The research results are attached in the form of narratives, frequency tables and graphs. The data will be processed statistically by a statistical consultant. Thus, data from SPs who dropped out will be included in the data analysis. The hypothesis test to assess changes in the primary end point (degree of melasma) during the study measurement series (baseline, M4, M8, M12) will be assessed using the Independent Sample T-test. Normality was tested using the Kolmogorov Smirnov normality test which was confirmed with the Coefficient of Variation. The data was processed statistically by a statistical consultant using SPSS® version 21.
- Conditions
- Melasma
- Being tested
- Pigment Solution Program
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pigment Solution ProgramDrug
adjuvant therapy for melasma that contains of combination formula consisting of morning cream - containing kojic acid, Vitamin E, Vitamin A and AquaxylTM complex; night cream - contains kojic acid, glycolic acid and AquaxylTM complex, scrub granules; and cleaning fluid containing vegetable oil and lactic acid.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (HQ group) | No intervention | Group 1 is control group, getting SPF 30 sunscreen cream in the morning and only 2% Hydroquinone cream at night without a combination cream and facial soap that can be used in the morning and evening. |
| Group 2 (PSP Group) | Experimental | Group 2, the treatment group, used PSP cleanser, PSP Day Cream and SPF 30 sunscreen in the morning and used Hydroquinone 2% and PSP Night Cream at night and PSP cleanser which was used in the morning and evening before using the cream. Receives: Drug: Pigment Solution Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score.
The range of values for mMASI is between 0 and 24 which can then be divided into mild melasma (0-8), moderate (8-16), and severe (16-24).
The range of values for mMASI is between 0 and 24 which can then be divided into mild melasma (0-8), moderate (8-16), and severe (16-24).
improvement occurs if the mMASI score decreases by <50% from the previous visit worsening if score persists or mMASI Score Increase >50%
Measured: re-evaluation on day 28, day 56 and day 84 of therapy
Change of Melasma Severity based on Investigator Global Assesment (IGA).
Assessment of response to therapy as follows:
- No effect: 0 (no visible change in Pigmentation)
- Mild: 1 (decreased visible pigmentation, but still visible boundaries)
- Moderate: 2 (obvious decrease in Pigmentation, but still limited visible)
- Very good: 3 (disappearance of all visible abnormalities Pigmentation) improvement if there is >50% improvement from the previous visit worsening if score persists or improvement <50%
Measured: re-evaluation on day 28, day 56 and day 84 of therapy
Change of Melasma Severity based on Investigator Tolerability Assesment (ITA).
is one method of evaluating patient tolerability of products which is assessed subjectively by investigators.
Assessment of patient tolerability as follows:
- 0 = no tolerability,
- 1 = moderate tolerability,
- 2 = good tolerability,
- 3 = very good tolerability. tolerability was good if the score improved >50% from the previous visit worsening if score persists or improvement <50%
Measured: re-evaluation on day 84 of therapy
Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA).
one method of evaluating the response to therapy in melasma which is assessed subjectively by the patient. The response to therapy can be assessed as follows
- No or slight response: < 25% improvement
- Moderate response: 25% - 50% improvement
- Good response: 50% improvement - < 75%
- Excellent response: improvement > 75%
The response is said to be good if the score is above 50% since the previous visit
Measured: re-evaluation on day 28, day 56 and day 84 of therapy
Change of Melanin and Erythema Index Based on Mexameter
improves if there is a decrease in melanin levels > 50% from the initial visit It is said to be bad or persistent if there is no decrease in melanin levels or there is a decrease of <50%
Measured: re-evaluation on day 28, day 56 and day 84 of therapy
Change of Melasma Severity based on Dermoscopy
based on Dermoscopy
Telangiectasis score assessment using a 5-point dermoscopy-scale:
0 = No visible capillaries.
1 = Elongated capillaries accompanied by dilation, not visible to the naked eye. 2 = Moderate telangiectasis that is beginning to be visible to the naked eye.
3 = Severe telangiectasis characterized by reduced capillary loops. 4 = Very severe telangiectasis characterized by dilatation and loss of capillary loops.
Measured: re-evaluation on day 84 of therapy
Change of Melasma Severity based on Wood's Lamp
Epidermal Type/ Dermal Typed/ Mixed Typed
Measured: re-evaluation on day 84 of therapy
Compare Quality Of Life based on MelasQoL Score
based on MelasQoL Score minimum score: 7 maximum score : 70
Measured: re-evaluation on day 84 of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start25 Sep 2023
- Primary completion18 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Collaborators
- Menarini Group
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174545
- Sponsor's protocol ID
- PSP
- Status last verified
- Dec 2023
- First submitted
- 7 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma
- ClinicalTrials.gov ID
- NCT06174545
- Acronym / sponsor ID
- PSP
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Collaborators
- Menarini Group
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 18 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Dec 2023 (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.
This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in multicenters at two Dermatology and Venereology Education centers in Indonesia.
This study aims to determine the effectiveness and safety of PSP as adjuvant therapy for melasma.
This research will be attended by 33 research subjects
Detailed description
Melasma is one of the most common hyperpigmentary dermatoses, found mostly in Asian or Hispanic people living in tropical areas.
The goal of melasma treatment is to remove existing pigmentation and to inhibit pigmentation. Until now, hydroquinone (HQ) is still used as the Gold Standard for melasma therapy.
Various epidemiological studies calculate the prevalence of melasma, it is estimated that the prevalence of melasma is 1% in the general population and in high risk populations it is 9 - 50%. This large variation is due to differences in skin type, ethnicity, and level of UV exposure
The diagnosis of melasma is based on the clinical picture, namely light to dark brown macules with irregular edges and a distribution that tends to be symmetrical, especially on the face. Supporting examinations can be carried out to determine the degree of melasma and monitor the therapy given.
This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in multicenters at two Dermatology and Venereology Education centers in Indonesia. The number of samples was 33 divided into 2 groups based on consecutive sampling to obtain subjects who met the eligibility criteria. Then subjects will be allocated into two groups using block randomization.
What is meant by group 1 is control, getting SPF 30 sunscreen cream in the morning and only 2% Hydroquinone cream at night without a combination cream and facial soap that can be used in the morning and evening. Meanwhile, group 2, the treatment group, used PSP cleanser, PSP Day Cream and SPF 30 sunscreen in the morning and used Hydroquinone 2% and PSP Night Cream at night and PSP cleanser which was used in the morning and evening before using the cream.
Data collection and research will be carried out for 3 months and data management and analysis will be carried out for the following 1 month. Follow up will be carried out at Week 4, Week 8 and Week 12. Each follow up will be analyzed as follows:
- Physical examination
- 5 position face photos
- Mexameter examination
- Dermoscopic examination
- Check wood lamp
- MelasQoL check
- Calculation of mMASI Score
- Completing the Investigator's Global Assessment questionnaire
- Completing the Patient's Global Assessment Questionnaire
- Completing the Investigator's Tolerability Assessment questionnaire
Data is recorded in research status which is then compiled into a master table. After recording the research results is complete, the masking code is opened for statistical analysis. Data analysis used statistical tests in accordance with the intention to treat approach with research subject analysis methods based on intervention groups. The research results are attached in the form of narratives, frequency tables and graphs. The data will be processed statistically by a statistical consultant. Thus, data from SPs who dropped out will be included in the data analysis. The hypothesis test to assess changes in the primary end point (degree of melasma) during the study measurement series (baseline, M4, M8, M12) will be assessed using the Independent Sample T-test. Normality was tested using the Kolmogorov Smirnov normality test which was confirmed with the Coefficient of Variation. The data was processed statistically by a statistical consultant using SPSS® version 21.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (HQ group) | No intervention | –Group 1 is control group, getting SPF 30 sunscreen cream in the morning and only 2% Hydroquinone cream at night without a combination cream and facial soap that can be used in the morning and evening. |
| Group 2 (PSP Group) | Experimental | Drug: Pigment Solution ProgramGroup 2, the treatment group, used PSP cleanser, PSP Day Cream and SPF 30 sunscreen in the morning and used Hydroquinone 2% and PSP Night Cream at night and PSP cleanser which was used in the morning and evening before using the cream. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women aged 30-60 years
- Fitzpatrick skin phototype IV-V
- Diagnosis of epidermal, mixed and dermal types of Melasma
Key exclusion criteria (6 listed)
- Are pregnant or breastfeeding
- Use other lightening agents, both oral and topical
- Allergy to PSP content
- Use of other topical therapies for skin disorders may interfere with the evaluation of melasma conditions
- Suffering from other skin diseases such as acne, dermatitis
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 |
|---|---|---|
| Pigment Solution Programadjuvant therapy for melasma that contains of combination formula consisting of morning cream - containing kojic acid, Vitamin E, Vitamin A and AquaxylTM complex; night cream - contains kojic acid, glycolic acid and AquaxylTM complex, scrub granules; and cleaning fluid containing vegetable oil and lactic acid. | Drug | Group 2 (PSP Group) |
Primary outcome
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score.
Time frame: re-evaluation on day 28, day 56 and day 84 of therapy
The range of values for mMASI is between 0 and 24 which can then be divided into mild melasma (0-8), moderate (8-16), and severe (16-24). The range of values for mMASI is between 0 and 24 which can then be divided into mild melasma (0-8), moderate (8-16), and severe (16-24). improvement occurs if the mMASI score decreases by <50% from the previous visit worsening if score persists or mMASI Score Increase >50%
Change of Melasma Severity based on Investigator Global Assesment (IGA).
Time frame: re-evaluation on day 28, day 56 and day 84 of therapy
Assessment of response to therapy as follows: * No effect: 0 (no visible change in Pigmentation) * Mild: 1 (decreased visible pigmentation, but still visible boundaries) * Moderate: 2 (obvious decrease in Pigmentation, but still limited visible) * Very good: 3 (disappearance of all visible abnormalities Pigmentation) improvement if there is >50% improvement from the previous visit worsening if score persists or improvement <50%
Change of Melasma Severity based on Investigator Tolerability Assesment (ITA).
Time frame: re-evaluation on day 84 of therapy
is one method of evaluating patient tolerability of products which is assessed subjectively by investigators. Assessment of patient tolerability as follows: * 0 = no tolerability, * 1 = moderate tolerability, * 2 = good tolerability, * 3 = very good tolerability. tolerability was good if the score improved >50% from the previous visit worsening if score persists or improvement <50%
Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA).
Time frame: re-evaluation on day 28, day 56 and day 84 of therapy
one method of evaluating the response to therapy in melasma which is assessed subjectively by the patient. The response to therapy can be assessed as follows * No or slight response: < 25% improvement * Moderate response: 25% - 50% improvement * Good response: 50% improvement - < 75% * Excellent response: improvement > 75% The response is said to be good if the score is above 50% since the previous visit
Change of Melanin and Erythema Index Based on Mexameter
Time frame: re-evaluation on day 28, day 56 and day 84 of therapy
improves if there is a decrease in melanin levels > 50% from the initial visit It is said to be bad or persistent if there is no decrease in melanin levels or there is a decrease of <50%
Change of Melasma Severity based on Dermoscopy
Time frame: re-evaluation on day 84 of therapy
based on Dermoscopy Telangiectasis score assessment using a 5-point dermoscopy-scale: 0 = No visible capillaries. 1 = Elongated capillaries accompanied by dilation, not visible to the naked eye. 2 = Moderate telangiectasis that is beginning to be visible to the naked eye. 3 = Severe telangiectasis characterized by reduced capillary loops. 4 = Very severe telangiectasis characterized by dilatation and loss of capillary loops.
Change of Melasma Severity based on Wood's Lamp
Time frame: re-evaluation on day 84 of therapy
Epidermal Type/ Dermal Typed/ Mixed Typed
Compare Quality Of Life based on MelasQoL Score
Time frame: re-evaluation on day 84 of therapy
based on MelasQoL Score minimum score: 7 maximum score : 70
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang 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 Pigment Solution Program in people with Melasma, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang (+62818130761, irma_bernadette@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score. (time frame: re-evaluation on day 28, day 56 and day 84 of therapy). The study lists 8 primary outcomes in all. 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 18 Dec 2023.