Melasma Clinical Trial
Official title:
Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma
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
Status | Recruiting |
Enrollment | 33 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 18, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Dr.dr.Irma Bernadette, SpKK (K) | Menarini Group |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Change of Melasma Severity based on Wood's Lamp | Epidermal Type/ Dermal Typed/ Mixed Typed | re-evaluation on day 84 of therapy | |
Primary | 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 |
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