Atrophic Varicella ScarPhase 2NCT00422539
Efficacy of TCA Effect on Varicella Atrophic Scars
A Phase 2 study testing 70% trichloroacetic acid in people with Atrophic Varicella Scar, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
This study aims to determine the efficacy of 70% trichloroacetic acid on atrophic scars of varicella Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Varicella Scar
- What is being tested?
- 70% trichloroacetic acid
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Mar 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Atrophic varicella scar on face
Who cannot join
- Active varicella infection
- Active Herpetic infection
- Previous history of keloid formation
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Skin Research Center, Shohada-e Tajrish Hospital, shaheed Beheshti Medical University
Tehran, Tehran Province, 198994148
About this study
Official title: Evaluation of Tri Chloro Acetic Acid (TCA) Effect on Atrophic Varicella Scars
This study aims to determine the efficacy of 70% trichloroacetic acid on atrophic scars of varicella
Read the detailed description
high concentration trichloroacetic acid peeling has been shown to be effective in treating and flattening the atrophic acne scars. According to the lack of an effective and low cost therapy for removing these relative common and nuisance lesions; We aimed to answer that whether we could achieve the same results from 70% TCA on atrophic varicella scars.
- Conditions
- Atrophic Varicella Scar
- Being tested
- 70% trichloroacetic acid
- Keywords
- trichloroacetic acid, varicella scar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
70% trichloroacetic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Clearance(before and after photographies were taken)
Secondary outcomes (2)
Subjective Clearance(according to the patients satisfaction)
Adverse effects(assessed by clinician as erythema, pigmentary changes, scaring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Varicella ScarStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Parviz Toossi, M.D., Study chair, Skin Research Center of Shaheed Beheshti medical UniversityBehrooz Barikbin, M.D., Principal investigator, Skin Research Center of Shaheed Beheshti Medical Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422539
- Sponsor's protocol ID
- SRC-BBA-1385-6-1
- Status last verified
- Jan 2007
- First submitted
- 16 Jan 2007
- Last updated
- 17 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tri Chloro Acetic Acid (TCA) Effect on Atrophic Varicella Scars
- ClinicalTrials.gov ID
- NCT00422539
- Acronym / sponsor ID
- SRC-BBA-1385-6-1
- Conditions
- Atrophic Varicella Scar
- Keywords
- trichloroacetic acid, varicella scar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2006
- First posted
- 17 Jan 2007 (estimated)
- 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 study aims to determine the efficacy of 70% trichloroacetic acid on atrophic scars of varicella
Detailed description
high concentration trichloroacetic acid peeling has been shown to be effective in treating and flattening the atrophic acne scars. According to the lack of an effective and low cost therapy for removing these relative common and nuisance lesions; We aimed to answer that whether we could achieve the same results from 70% TCA on atrophic varicella scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Atrophic varicella scar on face
Key exclusion criteria (3 listed)
- Active varicella infection
- Active Herpetic infection
- Previous history of keloid formation
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 |
|---|---|---|
| 70% trichloroacetic acid | Drug | – |
Primary outcome
Objective Clearance(before and after photographies were taken)
2 secondary outcomes
Subjective Clearance(according to the patients satisfaction)
Adverse effects(assessed by clinician as erythema, pigmentary changes, scaring)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2007.
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.
Parviz Toossi, M.D. study chair
Skin Research Center of Shaheed Beheshti medical University
Behrooz Barikbin, M.D. principal investigator
Skin Research Center of Shaheed Beheshti Medical Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 70% trichloroacetic acid in people with Atrophic Varicella Scar, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Jan 2007. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Behrooz Barikbin, M.D. (98-21-22744393 ext. 5, bbarikbin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Clearance(before and after photographies were taken). 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 17 Jan 2007.