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| Name | Class |
|---|---|
| University of Missouri, Kansas City | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetaphil | Active Comparator | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily |
|
| Estradiol Cream 0.01% | Active Comparator | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol cream 0.01% | Drug | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tazim Dowlut-McElroy, MD | University of Missouri, Kansas City | Principal Investigator |
| Julie L Strickland, MD, MPH | University of Missouri-Kansas City; Children's Mercy Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospitals & Clinics | Kansas City | Missouri | 64108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetaphil | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily |
| FG001 | Estradiol Cream 0.01% | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cetaphil | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily |
| BG001 | Estradiol Cream 0.01% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 3 weeks and 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cetaphil | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vulvar irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tazim Dowlut-McElroy, M.D., M.S. | University of Missouri-Kansas City School of Medicine | 816-404-5150 | tdowlut@cmh.edu |
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| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| C011189 | cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Cetaphil | Drug | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily |
|
| 3 weeks and 6 weeks |
Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| % introital closure | Number | participants |
|
| Thickness of labial adhesion | Count of Participants | Participants |
|
| Urinary tract infection | Count of Participants | Participants |
|
| Vulvovaginitis | Count of Participants | Participants |
|
| Pain with activity | Count of Participants | Participants |
|
| Postvoid dribbling | Count of Participants | Participants |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 weeks and 6 weeks |
|
|
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | Estradiol Cream 0.01% | Apply a pea-sized amount to the labial adhesion with lateral traction twice daily Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily | 0 | 22 | 1 | 22 |
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| D000091662 | Genital Diseases |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| 6 weeks |
|
| Superiority |
| Treatment by time interaction | ANOVA | 0.425 | Superiority |