Prepubertal Labial AdhesionsNCT02218463
Treatment of Prepubertal Labial Adhesions
A study testing Estradiol cream 0.01% and Cetaphil in people with Prepubertal Labial Adhesions, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
First-line treatment for labial adhesions in prepubertal girls has been topical estrogen. This study aims to evaluate an alternative and less costly option of treatment with potentially less side effects. Read more about this study
- Who is it for?
- Ages 3 months to 12 years, women only
- Conditions the study is for
- Prepubertal Labial Adhesions
- What is being tested?
- Estradiol cream 0.01% and Cetaphil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2016
- Phase
- Interventional
- 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 3 months to 12 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Prepubertal girls ages 3 months to 12 years with labial adhesions
Who cannot join
- Presence of underlying dermatologic conditions such as lichen sclerosis, severe atopic dermatitis, psoriasis or vitiligo
- Presence of systemic conditions that can have vulvar manifestations such as Crohn's disease and Behçet disease
- Presence of disorders requiring immunosuppressant treatment
- Previous surgical separation of labial adhesions
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, 64108
About this study
Official title: Treatment of Prepubertal Labial Adhesions: A Prospective Comparison of Topical Emollient Versus Topical Estrogen.
First-line treatment for labial adhesions in prepubertal girls has been topical estrogen. This study aims to evaluate an alternative and less costly option of treatment with potentially less side effects.
Primary Hypothesis:
There will be a difference in complete resolution of labial adhesions with topical estrogen with lateral traction as compared to an emollient with lateral traction.
Read the detailed description
The etiology of labial adhesions is unclear but appears to be related to hypoestrogenism in combination with vulvar irritation. For many years, first-line treatment for labial adhesions in prepubertal girls has been topical estrogen. With the use of topical estrogen, 50% of labial adhesions resolve in 2 to 3 weeks and most labial adhesions resolve with 6 weeks of treatment. However, because topical estrogen is systemically absorbed, its use is associated with side effects such as breast budding, vulvar hyperpigmentation, vaginal bleeding. There is a high risk of recurrence of labial adhesions of up to 35% after treatment with topical estrogen. In addition, topical estrogen is costly. Therefore, there continues to be controversy over the optimal treatment of labial adhesions in prepubertal girls.
Generally, for medical treatment of labial adhesions, topical estrogen is applied to the adhesion whist applying gentle lateral traction to promote separation of the labia. It is, therefore, plausible that the lateral traction applied to the adhesion site is what ultimately results in the separation of the labial fusion, while the use of estrogen improves healing after mechanical separation.
This is a single site, prospective, randomized, double-blinded study evaluating the comparative effectiveness of topical estrogen with lateral traction versus topical emollient with lateral traction for the treatment of labial adhesions in prepubertal girls.
- Conditions
- Prepubertal Labial Adhesions
- Being tested
- Estradiol cream 0.01%, Cetaphil
- Keywords
- Vulvar disease, adhesions, topical therapy, Labial adhesions prepubertal girls, Labial agglutination, Labial fusion
- Medical subject headings
- Vulvar Diseases, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol cream 0.01%Drug
Also called Estrace Vaginal
Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
CetaphilDrug
Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
| Study group | Role | What they receive |
|---|---|---|
| Cetaphil | Active comparator | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily Receives: Drug: Cetaphil |
| Estradiol Cream 0.01% | Active comparator | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily Receives: Drug: Estradiol cream 0.01% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Resolution of Labial Adhesion.
The first assessment will be 3 weeks after initiation of treatment. The final assessment will be 6 weeks after initiation of treatment.
Measured: 3 weeks and 6 weeks
Secondary outcomes (1)
Composite Severity Scale of Labial Adhesion Over Time
Response to treatment of labial adhesion is dependent not only upon the size of the adhesion but also the thickness. A more accurate measurement of response to treatment would, therefore, incorporate both measurements. For this study, the percentage of closure of the introitus at presentation was assigned an ordinal value as follows: 1=25%, 2=50%, 3=75%, and 4=100%. The degree of thickness of the labial adhesion was also measured in a similar fashion: 1=thin, 2=intermediate and 3= thick. Those that were resolved received a rating of 0 on both scales. A composite severity scale was created by multiplying the value assigned to the percentage of introital closure by that assigned to the thickness of the adhesion for each of the 3 study visits. The composite severity scale ranged from 0 to 12. This allowed a comparison of treatment effect between each group over time wherein a lower composite severity score corresponded to a less severe labial adhesion.
Measured: 3 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionJun 2016
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 Prepubertal Labial AdhesionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri, Kansas City
- Responsible party
- Sponsor
- Investigators
- Tazim Dowlut-McElroy, MD, Principal investigator, University of Missouri, Kansas CityJulie L Strickland, MD, MPH, Study director, University of Missouri-Kansas City; Children's Mercy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218463
- Sponsor's protocol ID
- CMH14010039
- Status last verified
- Apr 2025
- First submitted
- 14 Aug 2014
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Prepubertal Labial Adhesions: A Prospective Comparison of Topical Emollient Versus Topical Estrogen.
- ClinicalTrials.gov ID
- NCT02218463
- Acronym / sponsor ID
- CMH14010039
- Conditions
- Prepubertal Labial Adhesions
- Keywords
- Vulvar disease, adhesions, topical therapy, Labial adhesions prepubertal girls, Labial agglutination, Labial fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of Missouri, Kansas City
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First-line treatment for labial adhesions in prepubertal girls has been topical estrogen. This study aims to evaluate an alternative and less costly option of treatment with potentially less side effects.
Primary Hypothesis:
There will be a difference in complete resolution of labial adhesions with topical estrogen with lateral traction as compared to an emollient with lateral traction.
Detailed description
The etiology of labial adhesions is unclear but appears to be related to hypoestrogenism in combination with vulvar irritation. For many years, first-line treatment for labial adhesions in prepubertal girls has been topical estrogen. With the use of topical estrogen, 50% of labial adhesions resolve in 2 to 3 weeks and most labial adhesions resolve with 6 weeks of treatment. However, because topical estrogen is systemically absorbed, its use is associated with side effects such as breast budding, vulvar hyperpigmentation, vaginal bleeding. There is a high risk of recurrence of labial adhesions of up to 35% after treatment with topical estrogen. In addition, topical estrogen is costly. Therefore, there continues to be controversy over the optimal treatment of labial adhesions in prepubertal girls.
Generally, for medical treatment of labial adhesions, topical estrogen is applied to the adhesion whist applying gentle lateral traction to promote separation of the labia. It is, therefore, plausible that the lateral traction applied to the adhesion site is what ultimately results in the separation of the labial fusion, while the use of estrogen improves healing after mechanical separation.
This is a single site, prospective, randomized, double-blinded study evaluating the comparative effectiveness of topical estrogen with lateral traction versus topical emollient with lateral traction for the treatment of labial adhesions in prepubertal girls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetaphil | Active comparator | Drug: CetaphilApply a pea-sized amount to the labial adhesion with lateral traction twice daily |
| Estradiol Cream 0.01% | Active comparator | Drug: Estradiol cream 0.01%Apply a pea-sized amount to the labial adhesion with lateral traction twice daily |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Prepubertal girls ages 3 months to 12 years with labial adhesions
Key exclusion criteria (4 listed)
- Presence of underlying dermatologic conditions such as lichen sclerosis, severe atopic dermatitis, psoriasis or vitiligo
- Presence of systemic conditions that can have vulvar manifestations such as Crohn's disease and Behçet disease
- Presence of disorders requiring immunosuppressant treatment
- Previous surgical separation of labial adhesions
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 |
|---|---|---|
| Estradiol cream 0.01%Also: Estrace VaginalApply a pea-sized amount to the labial adhesion with lateral traction twice daily | Drug | Estradiol Cream 0.01% |
| CetaphilApply a pea-sized amount to the labial adhesion with lateral traction twice daily | Drug | Cetaphil |
Primary outcome
Complete Resolution of Labial Adhesion.
Time frame: 3 weeks and 6 weeks
The first assessment will be 3 weeks after initiation of treatment. The final assessment will be 6 weeks after initiation of treatment.
1 secondary outcome
Composite Severity Scale of Labial Adhesion Over Time
Time frame: 3 weeks and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Tazim Dowlut-McElroy, MD principal investigator
University of Missouri, Kansas City
Julie L Strickland, MD, MPH study director
University of Missouri-Kansas City; Children's Mercy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estradiol cream 0.01% and Cetaphil in people with Prepubertal Labial Adhesions, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 4 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 23 Apr 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2019). 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?
Complete Resolution of Labial Adhesion. (time frame: 3 weeks and 6 weeks). 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 23 Apr 2025.