Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma

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

Study Overview

• Status: Recruiting
• Conditions: Melasma
• Intervention / Treatment: Drug: Pigment Solution Program

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 Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang; Phone Number: +62818130761; Email: irma_bernadette@yahoo.com
• Study Contact Backup: Name: dr. Lilik Norawati, SpKK Norawati; Phone Number: +628121107149; Email: liliknora21@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
      • Contact: Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang; Phone Number: 62818130761; Email: irma_bernadette@yahoo.com
      • Contact: dr. Lilik Norawat, Sp.KK, FINSDV Norawati; Phone Number: 628121107149; Email: liliknora21@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	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%	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%	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	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%	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.	re-evaluation on day 84 of therapy
Change of Melasma Severity based on Wood's Lamp	Epidermal Type/ Dermal Typed/ Mixed Typed	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	re-evaluation on day 84 of therapy

Collaborators and Investigators

• Sponsor: Dr.dr.Irma Bernadette, SpKK (K)
• Collaborators: Menarini Group

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): December 18, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: PSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No