Clinical trial NCT06174545: Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma
Official title: Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melasma
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Menarini Group
First posted: 2023-12-18
Enrollment: 33
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. women aged 30-60 years
2. Fitzpatrick skin phototype IV-V
3. Diagnosis of epidermal, mixed and dermal types of Melasma

Exclusion Criteria:

1. Are pregnant or breastfeeding
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

Primary outcomes:
measure: Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score.
timeFrame: re-evaluation on day 28, day 56 and day 84 of therapy
measure: Change of Melasma Severity based on Investigator Global Assesment (IGA).
timeFrame: re-evaluation on day 28, day 56 and day 84 of therapy
measure: Change of Melasma Severity based on Investigator Tolerability Assesment (ITA).
timeFrame: re-evaluation on day 84 of therapy
measure: Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA).
timeFrame: re-evaluation on day 28, day 56 and day 84 of therapy
measure: Change of Melanin and Erythema Index Based on Mexameter
timeFrame: re-evaluation on day 28, day 56 and day 84 of therapy
measure: Change of Melasma Severity based on Dermoscopy
timeFrame: re-evaluation on day 84 of therapy
measure: Change of Melasma Severity based on Wood's Lamp
timeFrame: re-evaluation on day 84 of therapy
measure: Compare Quality Of Life based on MelasQoL Score
timeFrame: re-evaluation on day 84 of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
References: