Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma
NCT ID: NCT06174545
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
33 participants
INTERVENTIONAL
2023-09-25
2023-12-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Group 1 (HQ group)
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.
No interventions assigned to this group
Group 2 (PSP Group)
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.
Pigment Solution Program
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.
Interventions
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Pigment Solution Program
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.
Eligibility Criteria
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Inclusion Criteria
2. Fitzpatrick skin phototype IV-V
3. Diagnosis of epidermal, mixed and dermal types of Melasma
Exclusion Criteria
2. Use other lightening agents, both oral and topical
3. Allergy to PSP content
4. Use of other topical therapies for skin disorders may interfere with the evaluation of melasma conditions
5. Suffering from other skin diseases such as acne, dermatitis
6. Using hormonal birth control
30 Years
60 Years
FEMALE
Yes
Sponsors
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Menarini Group
INDUSTRY
Dr.dr.Irma Bernadette, SpKK (K)
OTHER
Responsible Party
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Dr.dr.Irma Bernadette, SpKK (K)
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K)
Locations
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Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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Central Contacts
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Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang
Role: CONTACT
Phone: +62818130761
Email: [email protected]
Facility Contacts
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Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang
Role: primary
dr. Lilik Norawat, Sp.KK, FINSDV Norawati
Role: backup
Other Identifiers
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PSP
Identifier Type: -
Identifier Source: org_study_id