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

Primary Purpose

Facial Melasma

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Hydroquinone

Placebo

About this trial

This is an interventional treatment trial for Facial Melasma focused on measuring Facial Melasma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Clinic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydroquinone

Placebo

Arm Description

Hydroquinone 4% Cream will be applied in one side of the face while the other side of the face receives placebo. Half of the patients will receive Hydroquinone on the right side of the face and the other half on the left side. It will be applied daily, at night, during 8 weeks.

Placebo cream (vehicle of Hydroquinone 4% cream), will be applied in one side of the face, while the other side receives the active treatment. Half of the patients will receive Hydroquinone on the right side of the face and the other half on the left side. It will be applied daily, at night, during 8 weeks.

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

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

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

Full Information

NCT ID

NCT02095990

First Posted

March 21, 2014

Last Updated

September 27, 2019

Sponsor

Mesoestetic Pharma Group S.L.

1. Study Identification

Unique Protocol Identification Number

NCT02095990

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mesoestetic Pharma Group S.L.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facial Melasma

Keywords

Facial Melasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydroquinone

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Hydroquinone

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline, week 4, week 8.

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Week 4, Week 8, Follow-up period (Week 12)

Other Pre-specified Outcome Measures:

Title

To assess patients' satisfaction regarding Melanoderm 4% Crema.

Description

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.

Time Frame

Week 8

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susana Puig, MD

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clinic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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