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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
Est. primary completion date
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


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
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