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OpenTrials
Completed

NCT Number: NCT02095990

Efficacy and Safety of a 4% Hydroquinone Cream for the Treatment of Melasma

To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face, using a split-face randomization design, evaluating the MASI Score from baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo.

To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.

To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.

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Key information

Conditions

Facial Melasma

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult women aged between 18-65 years old.
  • Fitzpatrick phototypes I to IV.
  • Presenting moderate to severe facial melasma facial, with a basal Melasma Area and Severity Index (MASI Index) between 10 and 20.
  • Women of childbearing potential must use an adequate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment.
  • Breastfeeding women will not be included in the study.
  • Having given freely and expressly her informed consent.

Exclusion criteria

  • Those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products.
  • Fitzpatrick phototype V.
  • Skin pigmentation diseases different to melasma.
  • Evidence of active cancer disease or diagnosis of cancer in the last year.
  • Those receiving any topical or oral treatment that could interfere with melasma.
  • Pregnant or breastfeeding women, or those expecting to get pregnant during the study.
  • Evidence or suspicion of low compliance with the study visits and procedures.
  • Participation in other clinical trial simultaneously or in the previous 3 months.

Treatment and study plan

Hydroquinone

Drug

Placebo

Drug

Primary outcomes

  1. To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face.

    Time frame: Baseline, week 4, week 8.

    Efficacy assessments will be measured by the Melasma Area and Severity Index (MASI Index) at baseline, week 4 and week 8 (end of treatment).

Secondary outcomes

  1. To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.

    Time frame: Week 4, Week 8, Follow-up period (Week 12)

    Adverse events will be recorded throughout the study and 30 days after the end of treatment.

Other outcomes

  1. To assess patients' satisfaction regarding Melanoderm 4% Crema.

    Time frame: Week 8

    Patients' satisfaction in terms of efficacy and safety will be evaluated by a Visual Analogic Scale at week 8, which will be completed for each side of the face independently.

Sponsors and collaborators

Lead sponsor

Mesoestetic Pharma Group S.L.

Industry

Registry information

Official study title

Efficacy and Safety of a 4% Hydroquinone Cream (Melanoderm 4%) for the Treatment of Melasma: a Randomized Controlled Split-face Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2014
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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