NCT00114660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

March 6, 2009

Status Verified

March 1, 2007

First QC Date

June 16, 2005

Last Update Submit

March 5, 2009

Conditions

Striae GravidarumPregnancy

Keywords

striae gravidarumstretch markscocoa butterprevention

Outcome Measures

Primary Outcomes (1)

  • Development of stretch marks

Interventions

Cocoa butter applicationDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primigravid women in first trimester of pregnancy

You may not qualify if:

  • Hypersensitivity of cocoa butter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

Related 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.

    PMID: 18715434RESULT

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hibah Osman, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2005

First Posted

June 17, 2005

Study Start

November 1, 2004

Study Completion

July 1, 2006

Last Updated

March 6, 2009

Record last verified: 2007-03

Locations

LE(1)