Cocoa Butter for Prevention of Stretch Marks

Pregnancy Clinical Trial

Official title:

Topical Application of Cocoa Butter for Prevention of Striae Gravidarum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114660
• Other study ID #: FM.HO.01
• Secondary ID: R588416
• Status: Completed
• Phase: N/A
• First received: June 16, 2005
• Last updated: March 5, 2009
• Start date: November 2004
• Est. completion date: July 2006

Study information

• Verified date: March 2007
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will check to see if using cocoa butter lotion on the belly, breasts and thighs will help reduce the appearance of stretch marks in pregnancy. Women entering the study will either receive a lotion containing cocoa butter with vitamin E or a lotion containing only vitamin E. After delivery, the study investigators will evaluate whether the women who used cocoa butter lotion were less likely to develop stretch marks.

Description:

Primigravid women presenting for prenatal care in the first trimester will be recruited to participate in the study. They will be randomly assigned to receive the study lotion (a commercially available lotion containing cocoa butter with viatmin E), a placebo lotion (a lotion containing vitamin E but no cocoa butter). Participants and investigators will be blinded to the lotion assignment.

Women will be asked to apply a thin layer of the lotion to their abdomen, breasts and thighs once daily until the date of delivery. Participants will be recruited as early in their pregnancy as possible but will not be asked to start applying the lotion before 12 weeks of pregnancy. Women presenting after 20 weeks of pregnancy will not be eligible to participate in the study. The cocoa butter and placebo lotions have been made up to look, smell and feel the same and will be provided to the participants in identical containers. Women who have known hypersensitivity to cocoa butter or any of the components of the lotion will be excluded from the study.

Participants will be assessed at study entry for presence of stretch marks. Baseline information will be collected at that time including pre-pregnancy weight, skin type, and history of stretch marks in the mother or siblings. Women will then be followed up monthly by telephone to assess compliance with the regimen and ensure that they are not developing skin reactions.

Participants will be assessed for the development of stretch marks after delivery. Women will also be asked to provide their own assessment of their skin condition in terms of presence/absence of stretch marks and their severity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primigravid women in first trimester of pregnancy

Exclusion Criteria:

• Hypersensitivity of cocoa butter

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy
• Striae Gravidarum

Intervention

Drug:
• Cocoa butter application

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Wellcome Trust

Country where clinical trial is conducted

Lebanon, 

References & Publications (1)

Osman H, Usta IM, Rubeiz N, Abu-Rustum R, Charara I, Nassar AH. Cocoa butter lotion for prevention of striae gravidarum: a double-blind, randomised and placebo-controlled trial. BJOG. 2008 Aug;115(9):1138-42. doi: 10.1111/j.1471-0528.2008.01796.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of stretch marks