Evaluating a new treatment for melasma using a pigment solution program
Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma
This study is testing a new pigment solution program to see if it can help women with melasma get better results than standard treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | Female |
| Sponsor | Indonesia University Academic / other |
| Locations | 1 site (Jakarta Pusat, DKI Jakarta) |
| Trial ID | NCT06174545 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effectiveness and safety of the Pigment Solution Program (PSP) as an adjuvant therapy for melasma. Conducted as a single-blind randomized controlled trial across two dermatology centers in Indonesia, the study will involve 33 women aged 30-60 with specific skin types and diagnosed melasma. Participants will be divided into two groups, with one receiving standard treatment and the other receiving the new PSP treatment alongside standard care. The aim is to assess whether PSP can improve treatment outcomes for melasma compared to conventional methods.
Who should consider this trial
Good fit: Ideal candidates are women aged 30-60 with Fitzpatrick skin phototype IV-V diagnosed with epidermal, mixed, or dermal types of melasma.
Not a fit: Patients who are pregnant, breastfeeding, or using other skin lightening agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for managing melasma, improving skin appearance and patient quality of life.
How similar studies have performed: While there is existing research on melasma treatments, the specific use of the Pigment Solution Program as an adjuvant therapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jakarta Pusat, DKI Jakarta
- Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo — Jakarta Pusat, DKI Jakarta, Indonesia (Recruiting)
Study contacts
- Study coordinator: Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang
- Email: irma_bernadette@yahoo.com
- Phone: +62818130761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.