Xanthelasma PalpebrarumNCT06839638
Efficacy of 100% Trichloroacetic Acid Vs. Cryotherapy in Xanthelasma Palpebrarum
A study testing 100% Trichloroacetic Acid (TCA) and Cryotherapy (Liquid Nitrogen) in people with Xanthelasma Palpebrarum, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
Xanthelasma palpebrarum (XP) is a common skin condition characterized by yellowish plaques that typically develop around the eyelids. While not harmful, these plaques can be a cosmetic concern for many individuals. Several treatment options exist, but there is no clear consensus on the most effective method. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Xanthelasma Palpebrarum
- What is being tested?
- 100% Trichloroacetic Acid (TCA) and Cryotherapy (Liquid Nitrogen)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Sep 2024to 7 Apr 2025
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 20-55 years
- Either male or female
- No prior treatment for xanthelasma palpebrarum (XP)
- Patients on anti-lipidemic drugs for systemic control of disease
- Bilateral xanthelasmas measuring between 0.5 cm to 3 cm
Who cannot join
- History of hypersensitivity to TCA or cryotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Trichloroacetic Acid (100%) Versus Cryotherapy in Patients with Xanthelasma Palpebrarum
Xanthelasma palpebrarum (XP) is a common skin condition characterized by yellowish plaques that typically develop around the eyelids. While not harmful, these plaques can be a cosmetic concern for many individuals. Several treatment options exist, but there is no clear consensus on the most effective method.
This study aims to compare the effectiveness of two treatment options-100% trichloroacetic acid (TCA) and cryotherapy-in removing xanthelasma palpebrarum. Trichloroacetic acid is a chemical solution that removes the lesions by controlled cauterization, while cryotherapy involves freezing the plaques using liquid nitrogen.
Read more
A total of 60 patients with xanthelasma will be randomly assigned to receive either 100% TCA or cryotherapy. The success of the treatment will be determined based on whether the plaques flatten and disappear within six weeks. The results of this study will help identify the more effective treatment method, which can be used to improve patient outcomes and minimize recurrence.
The study is being conducted at Nishtar Hospital Multan and aims to provide valuable insights for dermatologists in choosing the best treatment for xanthelasma palpebrarum.
Read the detailed description
Xanthelasma palpebrarum (XP) is a common dermatological condition characterized by the presence of yellowish plaques around the inner canthus of the eyelids. While benign, these plaques are often a significant cosmetic concern for patients. Various treatment modalities are available, including surgical excision, laser therapy, electrocauterization, chemical cauterization with trichloroacetic acid (TCA), and cryotherapy. However, each treatment option has its limitations, including variable efficacy, risk of recurrence, and potential side effects. Despite the availability of multiple therapeutic approaches, no consensus exists regarding the most effective and cosmetically acceptable treatment for XP.
This randomized controlled trial aims to compare the efficacy of 100% trichloroacetic acid (TCA) versus cryotherapy (liquid nitrogen) for the treatment of xanthelasma palpebrarum. TCA is a commonly used chemical cauterizing agent that causes epidermal necrosis, leading to the sloughing of lipid-laden histiocytes responsible for XP formation. Cryotherapy, on the other hand, involves the application of extreme cold to induce tissue destruction, promoting lesion resolution. Both modalities are non-surgical, cost-effective, and relatively simple to perform, making them viable options for outpatient dermatological treatment.
Sixty patients with xanthelasma palpebrarum will be enrolled in the study and randomly allocated into two treatment groups. Group A will receive 100% TCA application using the dipstick method, ensuring controlled application while protecting the surrounding skin with white soft paraffin. Group B will be treated with cryotherapy, using a single freeze-thaw cycle with liquid nitrogen until a narrow halo of white ice forms around the lesion. Following the procedure, all patients will apply Fusidic acid 2% twice daily for one week as post-treatment care.
The primary outcome measure will be the complete resolution of xanthelasma, assessed at six weeks after treatment through clinical examination and photographic documentation. The study will also evaluate secondary outcomes, including post-treatment adverse effects such as hypopigmentation, erythema, ulceration, and scarring. A blinded consultant dermatologist will assess treatment response and determine efficacy based on predefined criteria.
This study is particularly significant as there is currently no published comparative study from South Punjab evaluating these two treatment modalities. By providing evidence on the relative efficacy and safety of TCA and cryotherapy, this research will help dermatologists select the most effective, safe, and cosmetically acceptable treatment for XP. The findings may also contribute to future treatment guidelines, improving patient outcomes and reducing the need for retreatment in clinical practice.
- Conditions
- Xanthelasma Palpebrarum
- Being tested
- 100% Trichloroacetic Acid (TCA), Cryotherapy (Liquid Nitrogen)
- Keywords
- Hyperlipidemia-related Skin Lesions, Non-Surgical Treatment for Xanthelasma, Chemical Cauterization
- Medical subject headings
- Xanthomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% Trichloroacetic Acid (TCA)Procedure or surgery
Patients in this group will receive 100% TCA application to xanthelasma lesions using the dipstick method. The surrounding skin will be protected with white soft paraffin to prevent chemical spillage. Post-treatment, Fusidic acid 2% will be applied twice daily for one week. Treatment efficacy will be assessed after six weeks.
Cryotherapy (Liquid Nitrogen)Procedure or surgery
Patients in this group will receive cryotherapy using liquid nitrogen. A single freeze-thaw cycle will be performed until a narrow halo of white ice forms around the lesion. Post-treatment care will include Fusidic acid 2% applied twice daily for one week. Treatment efficacy will be assessed after six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group TCA | Experimental | will receive 100% TCA application to xanthelasma lesions using the dipstick method. Receives: Procedure: 100% Trichloroacetic Acid (TCA) |
| Group Cryotherapy | Active comparator | will receive cryotherapy using liquid nitrogen. A single freeze-thaw cycle will be performed until a narrow halo of white ice forms around the lesion. Receives: Procedure: Cryotherapy (Liquid Nitrogen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of 100% Trichloroacetic Acid (TCA) versus Cryotherapy in Xanthelasma Palpebrarum
Complete disappearance and flattening of xanthelasma plaques, assessed through clinical examination by a blinded dermatologist.
Measured: Six weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start7 Sep 2024
- Primary completion7 Apr 2025 (estimated)
- Study completion7 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xanthelasma PalpebrarumStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amra Batool, Nishtar Medical University
- Investigators
- Muhammad Irfan Jamil, Principal investigator, Nishtar Hospital, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839638
- Sponsor's protocol ID
- NishtarMU2
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Trichloroacetic Acid (100%) Versus Cryotherapy in Patients with Xanthelasma Palpebrarum
- ClinicalTrials.gov ID
- NCT06839638
- Acronym / sponsor ID
- NishtarMU2
- Conditions
- Xanthelasma Palpebrarum
- Keywords
- Hyperlipidemia-related Skin Lesions, Non-Surgical Treatment for Xanthelasma, Chemical Cauterization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 7 Sep 2024 (actual)
- Primary completion
- 7 Apr 2025 (estimated)
- Study completion
- 7 Apr 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
Xanthelasma palpebrarum (XP) is a common skin condition characterized by yellowish plaques that typically develop around the eyelids. While not harmful, these plaques can be a cosmetic concern for many individuals. Several treatment options exist, but there is no clear consensus on the most effective method.
This study aims to compare the effectiveness of two treatment options-100% trichloroacetic acid (TCA) and cryotherapy-in removing xanthelasma palpebrarum. Trichloroacetic acid is a chemical solution that removes the lesions by controlled cauterization, while cryotherapy involves freezing the plaques using liquid nitrogen.
A total of 60 patients with xanthelasma will be randomly assigned to receive either 100% TCA or cryotherapy. The success of the treatment will be determined based on whether the plaques flatten and disappear within six weeks. The results of this study will help identify the more effective treatment method, which can be used to improve patient outcomes and minimize recurrence.
The study is being conducted at Nishtar Hospital Multan and aims to provide valuable insights for dermatologists in choosing the best treatment for xanthelasma palpebrarum.
Detailed description
Xanthelasma palpebrarum (XP) is a common dermatological condition characterized by the presence of yellowish plaques around the inner canthus of the eyelids. While benign, these plaques are often a significant cosmetic concern for patients. Various treatment modalities are available, including surgical excision, laser therapy, electrocauterization, chemical cauterization with trichloroacetic acid (TCA), and cryotherapy. However, each treatment option has its limitations, including variable efficacy, risk of recurrence, and potential side effects. Despite the availability of multiple therapeutic approaches, no consensus exists regarding the most effective and cosmetically acceptable treatment for XP.
This randomized controlled trial aims to compare the efficacy of 100% trichloroacetic acid (TCA) versus cryotherapy (liquid nitrogen) for the treatment of xanthelasma palpebrarum. TCA is a commonly used chemical cauterizing agent that causes epidermal necrosis, leading to the sloughing of lipid-laden histiocytes responsible for XP formation. Cryotherapy, on the other hand, involves the application of extreme cold to induce tissue destruction, promoting lesion resolution. Both modalities are non-surgical, cost-effective, and relatively simple to perform, making them viable options for outpatient dermatological treatment.
Sixty patients with xanthelasma palpebrarum will be enrolled in the study and randomly allocated into two treatment groups. Group A will receive 100% TCA application using the dipstick method, ensuring controlled application while protecting the surrounding skin with white soft paraffin. Group B will be treated with cryotherapy, using a single freeze-thaw cycle with liquid nitrogen until a narrow halo of white ice forms around the lesion. Following the procedure, all patients will apply Fusidic acid 2% twice daily for one week as post-treatment care.
The primary outcome measure will be the complete resolution of xanthelasma, assessed at six weeks after treatment through clinical examination and photographic documentation. The study will also evaluate secondary outcomes, including post-treatment adverse effects such as hypopigmentation, erythema, ulceration, and scarring. A blinded consultant dermatologist will assess treatment response and determine efficacy based on predefined criteria.
This study is particularly significant as there is currently no published comparative study from South Punjab evaluating these two treatment modalities. By providing evidence on the relative efficacy and safety of TCA and cryotherapy, this research will help dermatologists select the most effective, safe, and cosmetically acceptable treatment for XP. The findings may also contribute to future treatment guidelines, improving patient outcomes and reducing the need for retreatment in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TCA | Experimental | Procedure: 100% Trichloroacetic Acid (TCA)will receive 100% TCA application to xanthelasma lesions using the dipstick method. |
| Group Cryotherapy | Active comparator | Procedure: Cryotherapy (Liquid Nitrogen)will receive cryotherapy using liquid nitrogen. A single freeze-thaw cycle will be performed until a narrow halo of white ice forms around the lesion. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 20-55 years
- Either male or female
- No prior treatment for xanthelasma palpebrarum (XP)
- Patients on anti-lipidemic drugs for systemic control of disease
- Bilateral xanthelasmas measuring between 0.5 cm to 3 cm
Key exclusion criteria (1 listed)
- History of hypersensitivity to TCA or cryotherapy.
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 |
|---|---|---|
| 100% Trichloroacetic Acid (TCA)Patients in this group will receive 100% TCA application to xanthelasma lesions using the dipstick method. The surrounding skin will be protected with white soft paraffin to prevent chemical spillage. Post-treatment, Fusidic acid 2% will be applied twice daily for one week. Treatment efficacy will be assessed after six weeks. | Procedure or surgery | Group TCA |
| Cryotherapy (Liquid Nitrogen)Patients in this group will receive cryotherapy using liquid nitrogen. A single freeze-thaw cycle will be performed until a narrow halo of white ice forms around the lesion. Post-treatment care will include Fusidic acid 2% applied twice daily for one week. Treatment efficacy will be assessed after six weeks. | Procedure or surgery | Group Cryotherapy |
Primary outcome
Efficacy of 100% Trichloroacetic Acid (TCA) versus Cryotherapy in Xanthelasma Palpebrarum
Time frame: Six weeks after treatment initiation
Complete disappearance and flattening of xanthelasma plaques, assessed through clinical examination by a blinded dermatologist.
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 21 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Muhammad Irfan Jamil principal investigator
Nishtar Hospital, Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% Trichloroacetic Acid (TCA) and Cryotherapy (Liquid Nitrogen) in people with Xanthelasma Palpebrarum, run by Nishtar Medical University at 1 site in Pakistan.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Feb 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 Pakistan. 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?
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?
Efficacy of 100% Trichloroacetic Acid (TCA) versus Cryotherapy in Xanthelasma Palpebrarum (time frame: Six weeks after treatment initiation). 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 21 Feb 2025.