Comparison of Effectiveness and Safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in the Treatment of Melasma

NCT06780644 | Not Yet Recruiting

• 1 other identifier: triple combination cream
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This Research is a clinical study with a single-blind randomized controlled trial of evaluators. Clinical trial Randomized Controlled Trial (RCT) design that compares the use of a triple combination cream of flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% with a triple cream combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05% in melasma therapy in RSCM-FKUI. This study aims to Assess the effectiveness and safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in melasma patients

Conditions

Melasma

Outcome Measures

Primary Outcomes (7)

• 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%

  re-evaluation on day 28, 56 and day 84 of therapy

• 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 84 of therapy

• 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

• Change of Melasma Severity based on Wood's Lamp

  Epidermal Type/ Dermal Typed/ Mixed Typed

  re-evaluation on day 84 of therapy

• Compare Quality Of Life based on MelasQoL Score

  based on MelasQoL Score minimum score: 7 maximum score : 70

  re-evaluation on day 28, 56 and day 84 of therapy

• Change of Melanin 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, 56 and day 84 of therapy

• Change of Erytema Index Based on Mexameter

  improves if there is a decrease in Erytema levels \> 50% from the initial visit It is said to be bad or persistent if there is no decrease in erythema levels or there is a decrease of \<50%

  re-evaluation on day 28, 56 and day 84 of therapy

Study Arms (2)

Group A ( Triple combination Group)

EXPERIMENTAL

Group A, The treatment group, getting sunscreen cream in the morning and triple combination flucinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream at night and facial soap that can be used in the morning and evening.

Drug: Triple combination cream

Group B (Triple Combination Group)

EXPERIMENTAL

Group B, the treatment group, getting sunscreen cream in the morning and triple combination of mometasone furoate 0.1%, hydroquinone 4%, tretinoin 0.05%, cream at night and facial soap that can be used in the morning and evening.

Drug: Triple combination cream

Interventions

Triple combination cream DRUG

1. Apply sunscreen SPF ≥30 in the morning on 2 knuckles 2. Apply triple combination cream containing hydroquinone 40 mg, tretinoin 0.5 mg, and fluocinolone acetonide 0.1 mg at night all over the face except the area around the eyes, 1 fingertip unit (FTU) or 1 knuckle.

Group A ( Triple combination Group)

Eligibility Criteria

• Age: 30 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• Diagnosed with melasma based on clinical and Wood's lamp examination
• years old
• Skin type IV or V

You may not qualify if:

• Plan to be pregnant and breastfeeding women during the study period ( 12 weeks)
• using or have used hormonal contraception in the last 6 months, or plan to use hormonal contraception during the study period (12 weeks)
• Using topical melasma treatments such as corticosteroids, tretinoin, hydroquinone, and other skin whitening or lightening treatments in at least the last 2 weeks.
• Have used topical therapy for melasma i.e. triple combination cream for at least 3 months and showed no significant improvement.
• Using systemic therapy for melasma, e.g. antioxidants, tranexamic acid in at least the last 4 weeks.\*
• History of eppeeling, laser or mechanical abrasion on the face in the last 6 months.\*
• Using photosensitizer drugs such as tetracycline, phenytoin, carbamazepine, and spironolactone in at least the last 4 weeks.
• Having other skin complaints that may interfere with the evaluation of melasma such as post-inflammatory hyperpigmentation, Hori nevus, Ota nevus, pigmented contact dermatitis, and other pigmentation disorders.
• Difficulty in adherence to treatment such as long distance from home, work schedules, and busy activities.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo Hospital

Central Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K)

CONTACT

+62818130761; irma_bernadette@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.DVE, Subsp. D.K.E

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: February 17, 2025
• Primary Completion: May 26, 2025
• Study Completion: September 1, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

ID (1)