We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Cocoa Butter for Prevention of Stretch Marks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00114660
Recruitment Status : Completed
First Posted : June 17, 2005
Last Update Posted : March 6, 2009
Wellcome Trust
Information provided by:
American University of Beirut Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Striae Gravidarum Pregnancy Drug: Cocoa butter application Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Topical Application of Cocoa Butter for Prevention of Striae Gravidarum
Study Start Date : November 2004
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Development of stretch marks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Primigravid women in first trimester of pregnancy

Exclusion Criteria:

  • Hypersensitivity of cocoa butter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114660

Layout table for location information
American University of Beirut
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Wellcome Trust
Layout table for investigator information
Principal Investigator: Hibah Osman, MD American University of Beirut Medical Center
Publications of Results:
Layout table for additonal information
Responsible Party: Dr. Fadia Homeidan, American University of Beirut
ClinicalTrials.gov Identifier: NCT00114660    
Other Study ID Numbers: FM.HO.01
First Posted: June 17, 2005    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: March 2007
Keywords provided by American University of Beirut Medical Center:
striae gravidarum
stretch marks
cocoa butter
Additional relevant MeSH terms:
Layout table for MeSH terms
Striae Distensae
Skin Manifestations