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

NCT06174545 | Unknown

• 1 other identifier: PSP
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Melasma

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

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.

Drug: Pigment Solution Program

Interventions

Pigment Solution Program DRUG

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.

Group 2 (PSP Group)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr.dr.Irma Bernadette, SpKK (K): lead
• Menarini Group: collaborator

Study Sites (1)

Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang

CONTACT

+62818130761; irma_bernadette@yahoo.com

dr. Lilik Norawati, SpKK Norawati

CONTACT

+628121107149; liliknora21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K)

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: December 18, 2023
• Study Start: September 25, 2023
• Primary Completion: December 18, 2023
• Study Completion: December 31, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

ID (1)