Prevention of Melasma Relapse During Summertime

Melasma Clinical Trial

Official title:

Prevention of Melasma Relapse During Summertime

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061839
• Other study ID #: 2013-A00073-42
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: February 12, 2014
• Start date: March 2013
• Est. completion date: October 2013

Study information

• Verified date: February 2014
• Source: Centre de Pharmacologie Clinique Applique a la Dermatologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: ANSM - Agence National de Sécurité du Médicament
• Study type: Interventional

Clinical Trial Summary

Main objective is to show that a photoprotective sunscreen having a protection against the visible light is more effective than a sunscreen having the same UVA AND UVB protection but with a low (weak) protection against the visible, to prevent the relapses of the melasma during the summertime.

Description:

40 melasma affected women will be included and randomized in two parallel groups (one group protected by a UVA+UVB+visible extended sunscreen and one group group protected by a UVA+UVB sunscreen).

There will be 3 visits: Baseline, T2.5months and T5months (final visit).

Products application frequency: twice daily(morning and afternoon) and additional applications every 2 hours in case of solar exposure.

Main evaluation criterion: the MASI score assessed from standardized photographs (system VISIA, Canfield Scientific, USA) at Baseline, middle and end of study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Melasma

Exclusion Criteria:

• Other pigmentary disorders associated (including PIH)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Melasma

Intervention

Other:
• Sunscream with visible light protection

• Sunscream

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre de Pharmacologie Clinique Applique a la Dermatologie	BIODERMA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between MASI scores before prevention treatment and after 6 months	MASI scores are evaluated by two physicians blinded to the treatment received on standardized pictures taken before treatment and after 6 months of summer period	6 months	No