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The goal of this clinical trial is to analyze the effectiveness of SM-hUCMSC secretome administered via microneedling and intradermal microinjection as adjuvant therapy to NB-UVB, compared with NB-UVB alone, in terms of repigmentation, onset of improvement, safety, patient satisfaction, and vitiligo recurrence. The main questions it aims to answer are:
Participants will be allocated into three groups as follows:
This study aims to analyze the effectiveness of SM-hUCMSC secretome administered via microneedling and intradermal microinjection as adjuvant therapy to NB-UVB, compared with NB-UVB alone, in terms of repigmentation, onset of improvement, safety, patient satisfaction, and vitiligo recurrence.
This quasi-experimental three-group study involves patients with nonsegmental vitiligo who meet the inclusion criteria at the Precious Me Clinic, Serpong.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | receives NB-UVB combined with microneedling and topical 10% secretome |
|
| Group B | Experimental | receives NB-UVB combined with intradermal secretome injection. |
|
| Group C | Experimental | receives NB-UVB alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NB-UVB combined with microneedling and topical 10% secretome | Other | Group A receives NB-UVB combined with microneedling and topical 10% secretome. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving ≥50% Repigmentation Assessed by Vitiligo Area Scoring Index (VASI) | The primary outcome is the proportion of patients achieving at least 50% repigmentation of target vitiligo lesions, measured using the Vitiligo Area Scoring Index (VASI). Repigmentation will be calculated as the percentage reduction in depigmented area compared to baseline. Assessment will be performed by blinded dermatologists using standardized clinical evaluation and validated scoring methods. | Baseline, Week 4, Week 8, Week 12 (primary endpoint), and Week 24 (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VASI Score from Baseline | The absolute change in VASI score (points) from baseline to each follow-up visit will be evaluated. VASI quantifies both the extent of vitiligo involvement and degree of depigmentation. Lower scores indicate clinical improvement. | Baseline, Week 4, Week 8, Week 12, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | The proportion (%) of patients experiencing local or systemic adverse events related to treatment will be recorded. Adverse events include erythema, pain, edema, infection, post-inflammatory hyperpigmentation, and other complications. Severity will be classified as mild, moderate, or severe. | From baseline to Week 12 |
Inclusion Criteria:
Exclusion Criteria:
Other phototherapy modalities (e.g., PUVA, excimer laser) within the past 3 months.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sukmawati Tansil Tan, Dr. | Contact | +6287871111318 | sukmawati@fk.untar.ac.id | |
| Yohanes Firmansyah, MD | Contact | +6281297934375 | yohanes@fk.untar.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Sukmawati Tansil Tan | Tarumanagara University | Principal Investigator |
| Yohanes Firmansyah | Universitas Tarumanagara | Study Director |
| Michael Jansen Politan |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Precious Me | Tangerang | Banten | 11440 | Indonesia |
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| receives NB-UVB combined with intradermal secretome injection | Other | Group B receives NB-UVB combined with intradermal secretome injection |
|
| NB-UVB alone | Drug | Group C receives NB-UVB alone |
|
| Time to Onset of Repigmentation |
Time (in weeks) from initiation of treatment to the first clinically observable repigmentation (≥10% repigmentation or perifollicular repigmentation), assessed by dermatologists based on clinical examination and standardized dermatological photography. |
| Up to Week 12 |
| Change in Dermatology Life Quality Index (DLQI) Score | Quality of life will be assessed using the Dermatology Life Quality Index (DLQI) questionnaire. The outcome will be expressed as the change in DLQI score (points) from baseline, with lower scores indicating improved quality of life. | Baseline, Week 12, Week 24 |
| Patient Satisfaction Measured by Likert Scale | Patient satisfaction will be assessed using a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied). The outcome will be reported as mean satisfaction score. | Week 12 and Week 24 |
| Patient Global Assessment (PGA) Score | Clinical improvement as perceived by patients will be evaluated using the Patient Global Assessment (PGA) scale (0-4), where higher scores indicate greater perceived improvement. | Week 12 and Week 24 |
| Recurrence Rate of Vitiligo |
The proportion (%) of patients experiencing recurrence, defined as ≥25% loss of previously repigmented area or development of new depigmented lesions, assessed using VASI and standardized dermatological photography. |
| Week 24 |
| Repigmentation Assessed by Standardized Dermatological Photography | Repigmentation will be evaluated using standardized dermatological photography with controlled lighting, positioning, and calibration. Images will be assessed by blinded dermatologists to estimate percentage of repigmentation (%), ensuring objective visual documentation. | Baseline, Week 4, Week 8, Week 12, Week 24 |
| Precious Me Clinic |
| Study Chair |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000097244 | Percutaneous Collagen Induction |
| D000089282 | Secretome |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
| D012046 | Rehabilitation |
| D055442 | Metabolome |
| D008660 | Metabolism |
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