Cocoa Butter for Prevention of Stretch Marks

Status Completed

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00114660
Study type	Interventional
Source	American University of Beirut Medical Center
Contact
Status	Completed
Phase	N/A
Start date	November 2004
Completion date	July 2006

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.