Vulvar Lichen SclerosusCollagendepNCT07450625
Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Lichen Sclerosus Treated With Fat Grafting
A study testing Autologous Fat Grafting (Lipofilling) and Collagendep Pink Beauty in people with Vulvar Lichen Sclerosus and Vulvar Atrophy, run by San Gallicano Dermatological Institute IRCCS.
Trial summary
This randomized, interventional study evaluates the efficacy of Collagendep Pink Beauty, an oral nutritional supplement, in reducing vulvar dryness in women with Genital Lichen Sclerosus (VLS) who are undergoing fat grafting treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus, Vulvar Atrophy
- What is being tested?
- Autologous Fat Grafting (Lipofilling) and Collagendep Pink Beauty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2026to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older.
- Clinical diagnosis of Genital Lichen Sclerosus.
- Patients with a clinical indication for autologous fat grafting (lipofilling) treatment.
- Ability to provide written informed consent.
- Willingness to comply with the study protocol and attend all scheduled follow-up visits.
Who cannot join
- Presence of active local or systemic infections.
- Current pregnancy or breastfeeding.
- Known hypersensitivity or allergy to any of the ingredients of the study product "Collagendep Pink Beauty" (e.g., collagen, hyaluronic acid, herbal extracts).
- Concurrent use of other oral supplements that might interfere with the evaluation of the study results.
- Patients with oncological pathologies (malignancies) in the vulvar area.
- Inability to guarantee adequate follow-up or compliance with the treatment regimen.
About this study
Official title: Study of the Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Genital Lichen Sclerosus Treated With Fat Grafting
This randomized, interventional study evaluates the efficacy of Collagendep Pink Beauty, an oral nutritional supplement, in reducing vulvar dryness in women with Genital Lichen Sclerosus (VLS) who are undergoing fat grafting treatment. Lichen sclerosus is a chronic inflammatory condition that leads to tissue hardening, loss of elasticity, and significant symptoms such as itching, pain, and dryness, which severely impact functional and emotional well-being. While fat grafting is a recognized regenerative therapy for stabilizing the disease, this study investigates whether a 4-month course of bioactive collagen peptides and functional ingredients can further improve mucosal hydration and symptom relief compared to fat grafting alone.
Read the detailed description
Lichen sclerosus is a chronic inflammatory disease primarily affecting the ano-genital area, characterized by sclerosis and tissue atrophy. Current medical treatments, such as long-term corticosteroid use, may exacerbate existing tissue atrophy. In recent decades, regenerative therapies like fat grafting (lipofilling) have shown effectiveness in improving symptoms and stabilizing the condition. This study aims to evaluate the synergistic effect of an oral formulation, Collagendep Pink Beauty, which contains hydrolysed collagen peptides (VERISOL®), extracts of Astragalus and Centella asiatica (Astrion™), low molecular weight hyaluronic acid (HyaSource® Vita Mini), and nucleotides (Ribocare®). These ingredients are intended to stimulate endogenous collagen production and exert a trophic action on the vaginal mucosa
- Conditions
- Vulvar Lichen Sclerosus, Vulvar Atrophy
- Being tested
- Autologous Fat Grafting (Lipofilling), Collagendep Pink Beauty
- Keywords
- Lichen Sclerosus, Regenerative Medicine, Collagen Peptides, Vulvar Dryness, Hyaluronic Acid, Sexual Function
- Medical subject headings
- Vulvar Lichen Sclerosus, Lichen Sclerosus et Atrophicus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat Grafting (Lipofilling)Procedure or surgery
Standard regenerative surgical procedure involving the harvesting, processing, and reinjection of autologous fat into the vulvar tissues affected by Lichen Sclerosus.
Collagendep Pink BeautyDietary supplement
Oral nutritional supplement containing bioactive collagen peptides (VERISOL®), hyaluronic acid, nucleotides, and herbal extracts (Astrion™). Dosage: 1 stick per day for 120 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Fat Grafting + Collagendep) | Experimental | Patients in this arm will undergo the standard surgical procedure of autologous fat grafting (lipofilling) for Genital Lichen Sclerosus. Additionally, they will receive oral supplementation with Collagendep Pink Beauty (1 drink stick per day) for a total duration of 4 months (120 days), starting from the day of surgery (T0). Receives: Procedure: Autologous Fat Grafting (Lipofilling); Dietary Supplement: Collagendep Pink Beauty |
| Control Group (Fat Grafting Only) | Active comparator | Patients in this arm will undergo the standard surgical procedure of autologous fat grafting (lipofilling) for Genital Lichen Sclerosus without any additional oral supplementation. Receives: Procedure: Autologous Fat Grafting (Lipofilling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Vulvar Dryness
Evaluation of the efficacy of Collagendep Pink Beauty in reducing vulvar dryness. This is measured using the "Vaginal Dryness" category of the Visual Analogue Scale (VAS), where 0 represents the complete absence of the symptom and 10 represents the maximum intensity
Measured: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3)
Secondary outcomes (3)
Improvement of Mucosal Hydration
Measured through Trans-Epidermal Water Loss (TEWL) analysis to evaluate skin barrier integrity and mucosal hydration
Measured: Baseline (T0) and 4 months (T2)
Improvement in Sexual Function
Measured using the Female Sexual Function Index (FSFI), which assesses six domains of sexual function through 19 items (score 0-5). Higher scores indicate better sexual function.
Measured: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3).
Patient Satisfaction with Treatment
Assessed with a single question: "How satisfied are you with the effectiveness of the treatment received?", using a 5-point Likert scale (0 = very dissatisfied; 4 = very satisfied)
Measured: 6 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start20 Feb 2026 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Lichen SclerosusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-center, two-arm clinical study comparing fat grafting alone versus fat grafting plus 4 months of oral supplementation with Collagendep Pink Beauty.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Gallicano Dermatological Institute IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450625
- Sponsor's protocol ID
- RS 400/ISG/25
- Acronym
- Collagendep
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Genital Lichen Sclerosus Treated With Fat Grafting
- ClinicalTrials.gov ID
- NCT07450625
- Acronym / sponsor ID
- Collagendep / RS 400/ISG/25
- Conditions
- Vulvar Lichen Sclerosus, Vulvar Atrophy
- Keywords
- Lichen Sclerosus, Regenerative Medicine, Collagen Peptides, Vulvar Dryness, Hyaluronic Acid, Sexual Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- San Gallicano Dermatological Institute IRCCSUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- 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 randomized, interventional study evaluates the efficacy of Collagendep Pink Beauty, an oral nutritional supplement, in reducing vulvar dryness in women with Genital Lichen Sclerosus (VLS) who are undergoing fat grafting treatment. Lichen sclerosus is a chronic inflammatory condition that leads to tissue hardening, loss of elasticity, and significant symptoms such as itching, pain, and dryness, which severely impact functional and emotional well-being. While fat grafting is a recognized regenerative therapy for stabilizing the disease, this study investigates whether a 4-month course of bioactive collagen peptides and functional ingredients can further improve mucosal hydration and symptom relief compared to fat grafting alone.
Detailed description
Lichen sclerosus is a chronic inflammatory disease primarily affecting the ano-genital area, characterized by sclerosis and tissue atrophy. Current medical treatments, such as long-term corticosteroid use, may exacerbate existing tissue atrophy. In recent decades, regenerative therapies like fat grafting (lipofilling) have shown effectiveness in improving symptoms and stabilizing the condition. This study aims to evaluate the synergistic effect of an oral formulation, Collagendep Pink Beauty, which contains hydrolysed collagen peptides (VERISOL®), extracts of Astragalus and Centella asiatica (Astrion™), low molecular weight hyaluronic acid (HyaSource® Vita Mini), and nucleotides (Ribocare®). These ingredients are intended to stimulate endogenous collagen production and exert a trophic action on the vaginal mucosa
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, single-center, two-arm clinical study comparing fat grafting alone versus fat grafting plus 4 months of oral supplementation with Collagendep Pink Beauty.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Fat Grafting + Collagendep) | Experimental | Procedure: Autologous Fat Grafting (Lipofilling), Dietary Supplement: Collagendep Pink BeautyPatients in this arm will undergo the standard surgical procedure of autologous fat grafting (lipofilling) for Genital Lichen Sclerosus. Additionally, they will receive oral supplementation with Collagendep Pink Beauty (1 drink stick per day) for a total duration of 4 months (120 days), starting from the day of surgery (T0). |
| Control Group (Fat Grafting Only) | Active comparator | Procedure: Autologous Fat Grafting (Lipofilling)Patients in this arm will undergo the standard surgical procedure of autologous fat grafting (lipofilling) for Genital Lichen Sclerosus without any additional oral supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged 18 years or older.
- Clinical diagnosis of Genital Lichen Sclerosus.
- Patients with a clinical indication for autologous fat grafting (lipofilling) treatment.
- Ability to provide written informed consent.
- Willingness to comply with the study protocol and attend all scheduled follow-up visits.
Key exclusion criteria (6 listed)
- Presence of active local or systemic infections.
- Current pregnancy or breastfeeding.
- Known hypersensitivity or allergy to any of the ingredients of the study product "Collagendep Pink Beauty" (e.g., collagen, hyaluronic acid, herbal extracts).
- Concurrent use of other oral supplements that might interfere with the evaluation of the study results.
- Patients with oncological pathologies (malignancies) in the vulvar area.
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 |
|---|---|---|
| Autologous Fat Grafting (Lipofilling)Standard regenerative surgical procedure involving the harvesting, processing, and reinjection of autologous fat into the vulvar tissues affected by Lichen Sclerosus. | Procedure or surgery | Control Group (Fat Grafting Only), Intervention Group (Fat Grafting + Collagendep) |
| Collagendep Pink BeautyOral nutritional supplement containing bioactive collagen peptides (VERISOL®), hyaluronic acid, nucleotides, and herbal extracts (Astrion™). Dosage: 1 stick per day for 120 days. | Dietary supplement | Intervention Group (Fat Grafting + Collagendep) |
Primary outcome
Reduction in Vulvar Dryness
Time frame: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3)
Evaluation of the efficacy of Collagendep Pink Beauty in reducing vulvar dryness. This is measured using the "Vaginal Dryness" category of the Visual Analogue Scale (VAS), where 0 represents the complete absence of the symptom and 10 represents the maximum intensity
3 secondary outcomes
Improvement of Mucosal Hydration
Time frame: Baseline (T0) and 4 months (T2)
Improvement in Sexual Function
Time frame: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3).
Patient Satisfaction with Treatment
Time frame: 6 months (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Fat Grafting (Lipofilling) and Collagendep Pink Beauty in people with Vulvar Lichen Sclerosus and Vulvar Atrophy, run by San Gallicano Dermatological Institute IRCCS.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Reduction in Vulvar Dryness (time frame: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3)). 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 4 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.