Striae GravidarumNCT00114660
Cocoa Butter for Prevention of Stretch Marks
A study testing Cocoa butter application in people with Striae Gravidarum and Pregnancy, run by American University of Beirut Medical Center at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Striae Gravidarum, Pregnancy
- What is being tested?
- Cocoa butter application
- How many people
- 200 participants
- Where
- 1 siteLebanon
- Study dates
- Nov 2004to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primigravid women in first trimester of pregnancy
Who cannot join
- Hypersensitivity of cocoa butter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Application of Cocoa Butter for Prevention of Striae Gravidarum
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.
Read the 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.
- Conditions
- Striae Gravidarum, Pregnancy
- Being tested
- Cocoa butter application
- Keywords
- striae gravidarum, stretch marks, cocoa butter, prevention
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa butter applicationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of stretch marks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2005 (estimated)
- Study startNov 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Striae GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Investigators
- Hibah Osman, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114660
- Sponsor's protocol ID
- FM.HO.01
- Other IDs
- R588416
- Status last verified
- Mar 2007
- First submitted
- 16 Jun 2005
- Last updated
- 6 Mar 2009
- Results posted
- No
Publications
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.
PubMed 18715434
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of Cocoa Butter for Prevention of Striae Gravidarum
- ClinicalTrials.gov ID
- NCT00114660
- Acronym / sponsor ID
- FM.HO.01
- Conditions
- Striae Gravidarum, Pregnancy
- Keywords
- striae gravidarum, stretch marks, cocoa butter, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Nov 2004
- Study completion
- Jul 2006 (actual)
- First posted
- 17 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primigravid women in first trimester of pregnancy
Key exclusion criteria (1 listed)
- Hypersensitivity of cocoa butter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocoa butter application | Drug | – |
Primary outcome
Development of stretch marks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
- Results publication: PubMed 18715434Osman 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hibah Osman, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa butter application in people with Striae Gravidarum and Pregnancy, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of stretch marks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2009.