Stretch MarksPhase 4NCT01027793
Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks
A Phase 4 study testing Tretinoin cream 0.005% and Superficial Dermabrasion in people with Stretch Marks and Striae, run by Hexsel Dermatology Clinic at 1 site in Brazil.
Trial summary
This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks. Read more about this study
- Who is it for?
- Ages 11 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stretch Marks, Striae, Treatment
- What is being tested?
- Tretinoin cream 0.005% and Superficial Dermabrasion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Aug 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female subjects, aged between 11 and 25 years
- Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method for at least 3 months prior the study
- Subjects that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks
- Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form
- Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol
- Subjects who had never received treatment for striae in the studied area
Who cannot join
- Subjects whose medical history and physical examination present clinical pathology, as marfan Syndrome, cushing, systemic autoimmune or neurological diseases
- Pregnant or women in breastfeeding, or women planning to become pregnant
- Previous treatment for striae in the local area of the study.
- Subjects that are in use of tretinoin or glycolic acid in the local area of the study.
- Presence of white striae in the local area of the study
- History of Connective Tissue Disease
Show all 13Show fewer
- History of keloid development or skin healing problems
- Subjects that are taking medications associated with striae development, as systemic corticosteroids, indinavir, hormonal replacement therapy
- Hypersensibility to retinoic acid
- Subjects who intend to get tan in the area of the study, through exposure of sun or tanning machines during the study
- Subjects that have a variation in their weight of more than 2 kg in a period of four months prior the study
- Predisposition for chronic inflammatory process
- Subjects with chronic diseases as diabetes, cardiopathy, neoplasm, HIV and autoimmune diseases (vitiligo, lupus)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, 90570 040
About this study
Official title: Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks
This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.
Read the detailed description
Healthy female subjects, from 11 t0 25 years old, that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks.
Thirty subjects will be randomly divided in two groups:
Group 1 will receive tretinoin cream that should be applied daily in areas affected by stretch marks.
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.
Subjects will be evaluated by pictures, measurement of width and length of stretch marks, using Mirror System(Canfield).
Biopsy to quantify alterations of epidermis and dermis of treated area, will be held pre-treatment and 2 weeks after the conclusion of treatment. For biopsy will be used a punch of 3mm.
The results will be evaluated two weeks after the conclusion of the interventions. An independent dermatologist, blinded for intervention, will analyse pictures pre and post treatment. This subjective evaluation will be performed using Global Aesthetic Improvement Scale.
Safety and adverse events will be assessed each visit.
- Conditions
- Stretch Marks, Striae, Treatment
- Being tested
- Tretinoin cream 0.005%, Superficial Dermabrasion
- Keywords
- Stretch marks, Striae, Tretinoin, Superficial dermabrasion
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tretinoin cream 0.005%Drug
Also called (Vitanol A, Stiefel)
Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.
Superficial DermabrasionDevice
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
| Study group | Role | What they receive |
|---|---|---|
| Tretinoin | Active comparator | Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. Receives: Drug: Tretinoin cream 0.005% |
| Superficial Dermabrasion | Active comparator | Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Receives: Device: Superficial Dermabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of Stretch Marks
Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Measured: Baseline and 16 weeks
Length of Stretch Marks
Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Measured: Baseline and 16 weeks
Secondary outcomes (2)
Global Aesthetic Improvement Scale
- Very much improved: Optimal cosmetic result for the implant in this patient
- Much improved: Marked improvement in appearance from the initial condition but not completely optimal for this patient; touch-up would slightly improve the result 3 - Improved: Obvious improvement in appearance from the initial condition, but touch-up or retreatment is indicated 4 - No change: Appearance essentially the same as the original condition 5 - Worse: Appearance worse than the original condition
Measured: 16 weeks
Patient Satisfaction
Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stretch MarksStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hexsel Dermatology Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doris Hexsel, Hexsel Dermatology Clinic
- Investigators
- Doris M Hexsel, MD, Principal investigator, Brazilian Center For Studies in Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027793
- Sponsor's protocol ID
- 11-CBED08-01
- Status last verified
- Jan 2021
- First submitted
- 8 Dec 2009
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks
- ClinicalTrials.gov ID
- NCT01027793
- Acronym / sponsor ID
- 11-CBED08-01
- Conditions
- Stretch Marks, Striae, Treatment
- Keywords
- Stretch marks, Striae, Tretinoin, Superficial dermabrasion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hexsel Dermatology ClinicUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.
Detailed description
Healthy female subjects, from 11 t0 25 years old, that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks.
Thirty subjects will be randomly divided in two groups:
Group 1 will receive tretinoin cream that should be applied daily in areas affected by stretch marks.
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.
Subjects will be evaluated by pictures, measurement of width and length of stretch marks, using Mirror System(Canfield).
Biopsy to quantify alterations of epidermis and dermis of treated area, will be held pre-treatment and 2 weeks after the conclusion of treatment. For biopsy will be used a punch of 3mm.
The results will be evaluated two weeks after the conclusion of the interventions. An independent dermatologist, blinded for intervention, will analyse pictures pre and post treatment. This subjective evaluation will be performed using Global Aesthetic Improvement Scale.
Safety and adverse events will be assessed each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tretinoin | Active comparator | Drug: Tretinoin cream 0.005%Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. |
| Superficial Dermabrasion | Active comparator | Device: Superficial DermabrasionGroup 2 will receive 16 sessions of dermabrasion that would be held in the research center. |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Female subjects, aged between 11 and 25 years
- Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method for at least 3 months prior the study
- Subjects that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks
- Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form
- Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol
Key exclusion criteria (13 listed)
- Subjects whose medical history and physical examination present clinical pathology, as marfan Syndrome, cushing, systemic autoimmune or neurological diseases
- Pregnant or women in breastfeeding, or women planning to become pregnant
- Previous treatment for striae in the local area of the study.
- Subjects that are in use of tretinoin or glycolic acid in the local area of the study.
- Presence of white striae in the local area of the study
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 |
|---|---|---|
| Tretinoin cream 0.005%Also: (Vitanol A, Stiefel)Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. | Drug | Tretinoin |
| Superficial DermabrasionGroup 2 will receive 16 sessions of dermabrasion that would be held in the research center | Device | Superficial Dermabrasion |
Primary outcome
Width of Stretch Marks
Time frame: Baseline and 16 weeks
Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Length of Stretch Marks
Time frame: Baseline and 16 weeks
Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
2 secondary outcomes
Global Aesthetic Improvement Scale
Time frame: 16 weeks
Patient Satisfaction
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Doris M Hexsel, MD principal investigator
Brazilian Center For Studies in Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tretinoin cream 0.005% and Superficial Dermabrasion in people with Stretch Marks and Striae, run by Hexsel Dermatology Clinic at 1 site in Brazil.
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 6 inclusion and 13 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 22 Jan 2021. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Width of Stretch Marks (time frame: Baseline and 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2021.