A randomized controlled pilot study of a proprietary combination versus sunscreen in melasma maintenance

Area of Science:

• Dermatology
• Cosmetic Science

Background:

• Melasma is a common hyperpigmentation disorder affecting skin types IV-VI.
• First-line treatments like triple combination therapy carry risks with prolonged use.
• Alternative and maintenance therapies are crucial for managing melasma effectively.

Purpose of the Study:

• To compare a proprietary combination (phenyl ethyl resorcinol, nonapeptide-1, aminoethyl phosphinic acid, antioxidants, sunscreen) with sunscreen alone for melasma maintenance.
• To evaluate the safety and impact on quality of life of the proprietary formulation.
• To assess the efficacy in limiting or reducing melasma and preventing recurrence post-initial treatment.

Main Methods:

• Prospective, double-blinded, parallel-group, randomized controlled pilot study over eight months.
• 46 subjects randomized into case (proprietary combination + sunscreen) and control (sunscreen only) groups.
• Three phases: initial triple combination, maintenance phase, and follow-up for relapse assessment.

Main Results:

• The proprietary combination group showed a consistent reduction in melasma area and severity index (MASI) scores.
• Melasma severity score and melanin index improved in the case group, though not statistically significant compared to the control.
• No significant added inconvenience reported with the proprietary combination compared to sunscreen alone.

Conclusions:

• The proprietary combination appears more effective than sunscreen alone for maintaining melasma remission.
• Larger sample sizes and longer follow-up periods are needed to confirm efficacy and statistical significance.
• The formulation offers a convenient maintenance option for melasma patients.