Cocoa Butter for Prevention of Stretch Marks

This study has been completed.
Sponsor:
Collaborator:
Wellcome Trust
Information provided by:
American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT00114660
First received: June 16, 2005
Last updated: March 5, 2009
Last verified: March 2007
  Purpose

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 Intervention
Striae Gravidarum
Pregnancy
Drug: Cocoa butter application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Topical Application of Cocoa Butter for Prevention of Striae Gravidarum

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • Development of stretch marks

Estimated Enrollment: 200
Study Start Date: November 2004
Study Completion Date: July 2006
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primigravid women in first trimester of pregnancy

Exclusion Criteria:

  • Hypersensitivity of cocoa butter
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114660

Locations
Lebanon
American University of Beirut
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Wellcome Trust
Investigators
Principal Investigator: Hibah Osman, MD American University of Beirut Medical Center
  More Information

Publications:
Responsible Party: Dr. Fadia Homeidan, American University of Beirut
ClinicalTrials.gov Identifier: NCT00114660     History of Changes
Other Study ID Numbers: FM.HO.01, R588416
Study First Received: June 16, 2005
Last Updated: March 5, 2009
Health Authority: Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:
striae gravidarum
stretch marks
cocoa butter
prevention

Additional relevant MeSH terms:
Striae Distensae
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014