Prepubertal Labial Adhesions
Conditions
Keywords
Vulvar disease, adhesions, topical therapy, Labial adhesions prepubertal girls, Labial agglutination, Labial fusion
Brief 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. 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.
Interventions
DRUGEstradiol cream 0.01%
Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
DRUGCetaphil
Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
Sponsors
University of Missouri, Kansas City
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
3 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Prepubertal girls ages 3 months to 12 years with labial adhesions
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Resolution of Labial Adhesion. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Severity Scale of Labial Adhesion Over Time | 3 weeks and 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| 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 | 22 |
| Total | 43 |
Baseline characteristics
| Characteristic | Cetaphil | Estradiol Cream 0.01% | Total |
|---|---|---|---|
| Age, Continuous | 33 months | 26 months | 29 months |
| % introital closure 100% | 11 participants | 11 participants | 22 participants |
| % introital closure 25% | 1 participants | 0 participants | 1 participants |
| % introital closure 50% | 5 participants | 4 participants | 9 participants |
| % introital closure 75% | 4 participants | 7 participants | 11 participants |
| Pain with activity Absent | 20 Participants | 21 Participants | 41 Participants |
| Pain with activity Present | 1 Participants | 1 Participants | 2 Participants |
| Postvoid dribbling Absent | 20 Participants | 22 Participants | 42 Participants |
| Postvoid dribbling Present | 1 Participants | 0 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Thickness of labial adhesion Intermediate | 14 Participants | 17 Participants | 31 Participants |
| Thickness of labial adhesion Thick | 2 Participants | 1 Participants | 3 Participants |
| Thickness of labial adhesion Thin | 5 Participants | 4 Participants | 9 Participants |
| Urinary tract infection Absent | 21 Participants | 20 Participants | 41 Participants |
| Urinary tract infection Present | 0 Participants | 2 Participants | 2 Participants |
| Vulvovaginitis Absent | 21 Participants | 22 Participants | 43 Participants |
| Vulvovaginitis Present | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 21 | 1 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
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.
Time frame: 3 weeks and 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cetaphil | Complete Resolution of Labial Adhesion. | 21 Participants |
| Estradiol Cream 0.01% | Complete Resolution of Labial Adhesion. | 22 Participants |
Comparison: Assessment of complete resolution between the 2 study arms.p-value: 0.206Fisher Exact
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.
Time frame: 3 weeks and 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cetaphil | Composite Severity Scale of Labial Adhesion Over Time | Baseline | 6.3 units on a scale | Standard Deviation 3.1 |
| Cetaphil | Composite Severity Scale of Labial Adhesion Over Time | 3 weeks | 2.3 units on a scale | Standard Deviation 2.4 |
| Cetaphil | Composite Severity Scale of Labial Adhesion Over Time | 6 weeks | 1.9 units on a scale | Standard Deviation 2.1 |
| Estradiol Cream 0.01% | Composite Severity Scale of Labial Adhesion Over Time | Baseline | 6.2 units on a scale | Standard Deviation 2 |
| Estradiol Cream 0.01% | Composite Severity Scale of Labial Adhesion Over Time | 3 weeks | 1.5 units on a scale | Standard Deviation 1.7 |
| Estradiol Cream 0.01% | Composite Severity Scale of Labial Adhesion Over Time | 6 weeks | 1.6 units on a scale | Standard Deviation 1.9 |
Comparison: Time Effectp-value: 0.0001ANOVA
Comparison: Treatment Effectp-value: 0.37ANOVA
Comparison: Treatment by time interactionp-value: 0.425ANOVA