Evaluating a new treatment for melasma using a pigment solution program

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.