The goal of this clinical trial is to evaluate the efficacy and safety of a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES when used as a moisturizer after QS-Nd:YAG 1064 nm low-fluence laser treatment for melasma and post-acne hyperpigmentation.
The study aims to answer the following main questions:
* Does the combination serum reduce hyperpigmented lesions after laser treatment for melasma and post-acne hyperpigmentation? * Does the serum improve skin hydration following laser therapy for melasma? * Is the combination serum safe for use after laser treatment, without causing irritation or adverse effects?
Participants will be female patients aged 18-60 years, clinically diagnosed with melasma or post-acne hyperpigmentation (skin types IV and V), who visit the Dermatology \& Venereology Outpatient Clinic for QS-Nd:YAG 1064 low-fluence laser treatment. All participants will have undergone a 2-week priming period using either 2% hydroquinone cream or the test serum prior to laser treatment. Written informed consent is required.
Participants will be randomly assigned to receive either the test serum or 2% hydroquinone cream based on a coded allocation. The product will be applied twice daily after facial cleansing, and sunscreen will be used 15 minutes before outdoor activities. Treatment lasts for 2 weeks, with participants recording application times and any adverse effects in a diary. Evaluations-including facial photography, mMASI, mexameter, dermoscopy, Wood's lamp, and PAHPI-will be conducted at baseline and at 1, 2, and 4 weeks post-laser. Erythema and subjective assessment (VAS) will be performed 15 minutes after the laser procedure.
Female, aged 18-60 years.
Patients diagnosed with post-acne hyperpigmentation and melasma based on clinical examination and Wood's lamp evaluation, with Fitzpatrick skin types IV and V.
Patients visiting the Dermatology and Venereology Outpatient Clinic and scheduled to undergo QS Nd:YAG 1064 nm low-fluence laser treatment.
Pregnant, breastfeeding, or currently taking oral contraceptives at the time of evaluation.
History of systemic retinoid use within the past three months.
History of or ongoing treatment for hormonal/endocrine disorders or other severe systemic illnesses.
Currently undergoing immunosuppressive therapy.
Parallel
a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES
DrugSubjects were randomized to receive a combination serum The combination serum contained Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES. applied twice daily, following QS-Nd:YAG 1064 nm low-fluence laser treatment. Clinical evaluations were conducted at baseline and at Weeks 1, 2, and 4 post-laser to assess pigmentation improvement, erythema, and overall skin condition.
2% hydroquinone cream
DrugSubjects were randomized to received 2% hydroquinone cream, applied once daily at night, following QS-Nd:YAG 1064 nm low-fluence laser treatment. Clinical evaluations were conducted at baseline and at Weeks 1, 2, and 4 post-laser to assess pigmentation improvement, erythema, and overall skin condition.
Change of Subjective Pain Evaluation
Assessed using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain
Change of Eryhtema Score
Based on Clinical Erythema Assessment Scale. Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema
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). improvement occurs if the mMASI score decreases by \<50% from the previous visit worsening if score persists or mMASI Score Increase \>50%
Change of the Post-Acne Hyperpigmentation Index (PAHPI) score
On physical examination, the severity of post-inflammatory hyperpigmentation in patients with acne vulgaris was assessed using the Post-Acne Hyperpigmentation Index (PAHPI). The PAHPI score ranges from 6 to 22, with a score of 6 indicating mild post-acne hyperpigmentation and a score of 22 indicating severe post-acne hyperpigmentation.
Click on the lead sponsor to view all of their trials.
Dr.dr.Irma Bernadette, SpKK (K)
Lead sponsor
Indonesia University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
