ClinicalTrials.gg
CompletedNCT07716605Updated Jul 21, 2026

Effectiveness of Alovera Gel vs 1% Silver Sulfadiazine in Superficial Partial Thickness Burn Patients in Pediatric Population.

An interventional study of Silver sulfadiazine 1%cream and Alovera gel in Superficial and Superficial Partial Thickness Burns, sponsored by University of Child Health Sciences and Children's Hospital, Lahore. Completed at 1 site in Pakistan. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by University of Child Health Sciences and Children's Hospital, Lahore · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Feb 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Day to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Burns with a site in Pakistan — 4 open to participants now, 6 under way, none of them phase 3. Burns · Pakistan.

Enrollment
9th of 17
60 · median 60
Started
2025
with 2 others
No phase
14 of 17
4 open now
Registered
16th of 17
by date
Lead sponsor
1 of 17
University of Child Health Sciences and Children's Hospital, Lahore

Among the 17 studies in Burns with a site in Pakistan, this one is the 9th largest by enrollment, is one of 3 that started in 2025, is one of 14 with no phase, and was the 16th registered.

Burns

906 studies on the registry are indexed under Burns; 165 are open to participants now.

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Open to participants now

4 of the 17 studies in Burns with a site in Pakistan are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Pakistan have not opened yet or have stopped. Only those recruiting at a site in Pakistan →

Who these studies take

Of the 84 Burns studies recruiting now, 38 (45%) set no upper age limit and 37 (44%) stop at 75 or younger; 17 take children under 18; 9 take healthy volunteers.

This study: 1 Day to 18 Years · all sexes · no healthy volunteers.

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02

Study summary

This prospective randomized controlled study aims to compare the effectiveness of Aloe vera gel versus 1% silver sulfadiazine in the treatment of superficial and superficial partial-thickness burns in the pediatric population. Burn injuries are among the most common causes of morbidity in children, and optimal topical treatment is important for pain control, prevention of infection, and rapid wound healing.

Pediatric patients presenting with superficial and superficial partial-thickness burns will be enrolled and allocated into two treatment groups. One group will receive topical Aloe vera gel, while the other group will receive 1% silver sulfadiazine dressing according to standard burn care protocols. Patients will be followed regularly to assess wound healing progress, pain, infection rate, duration of healing, frequency of dressing changes, and any treatment-related complications. The primary outcome will be time to complete wound healing, while secondary outcomes will include pain score, infection rate, hospital stay, and scar formation.

Read the detailed description

Burn injuries are a significant cause of morbidity among the pediatric population and require effective topical therapy to promote wound healing, prevent infection, reduce pain, and minimize treatment cost. Silver sulfadiazine 1% cream is commonly used as a standard topical antimicrobial agent for superficial burns; however, delayed wound healing and frequent dressing requirements have encouraged the search for alternative therapies. Aloe vera has demonstrated anti-inflammatory, antimicrobial, soothing, and wound-healing properties in previous studies and may serve as an effective and economical alternative in burn management.

This randomized controlled trial will be conducted at The Children's Hospital \& Institute of Child Health Lahore over a duration of one year. A total of 60 pediatric patients aged 1 to 18 years presenting with superficial and superficial partial-thickness burns involving 1% to 25% total body surface area (TBSA) will be enrolled in the study. Patients will be randomly allocated into two groups by coin toss/lottery method. One group will receive topical Aloe vera gel dressing, while the second group will receive 1% silver sulfadiazine dressing. Dressings will be applied three times daily according to institutional burn care protocol.

Patients will be followed for a period of 14 days to assess treatment outcomes. The primary outcome measure will be the degree and rate of re-epithelialization of burn wounds. Secondary outcome measures will include pain relief, infection rate, and cost effectiveness of treatment. Patients with burns deeper than superficial partial-thickness burns, including deep second-degree and third-degree burns, as well as patients requiring surgical intervention or presenting with major associated comorbidities, will be excluded from the study.

03

Conditions studied

  • Superficial and Superficial Partial Thickness Burns

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04

Who can participate

Ages eligible
1 Day to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - Patients aged 1 to 18 years
  • Both male and female patients
  • Superficial and superficial partial-thickness burns
  • Burn extent involving 1% to 25% total body surface area (TBSA)
  • Presentation within acute phase of burn injury

Exclusion criteria

Exclusion Criteria:

  • - Deep partial-thickness (deep second-degree) or third-degree burns
  • Patients requiring surgical intervention (skin grafting)
  • Infected burns at presentation
  • Patients with major comorbidities affecting wound healing (e.g., immunodeficiency, diabetes mellitus)
  • Known to Aloe vera or silver sulfadiazine
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Other
    Arm-1: Alovera group

    Alovera gel applied 3 times daily until complete repithelization

    Other: Alovera gel

  • Other
    Silver sulfadiazine 1% topical cream

    Silver sulfadiazine applied 3 times daily until complete repithelization

    Drug: Silver sulfadiazine 1%cream

Interventions

  • DrugSilver sulfadiazine 1%cream

    Silver sulfadiazine applied 3 times daily until complete repithelization

  • OtherAlovera gel

    Alovera gel applied 3 times daily until complete repithelization

06

What researchers measure

Primary outcomes

  1. Degree of repithelization

    The primary outcome is the degree and rate of re-epithelialization of superficial and superficial partial-thickness burn wounds in pediatric patients. Wound healing will be assessed clinically by measuring percentage of wound closure and epithelial regeneration over a follow-up period of 14 days or until complete healing, whichever occurs earlier

    Time frame: 14 days

Secondary outcomes

  1. Pain relief

    Pain relief will be assessed using age-appropriate pain scoring systems (FLACC scale for younger children and Visual Analogue Scale for older children). Changes in pain scores will be recorded before and after treatment during the 14-day follow-up period.

    Time frame: 14 days

  2. Wound Infection

    The incidence of wound infection will be assessed clinically based on signs such as erythema, purulent discharge, increased pain, or fever during the treatment period

    Time frame: 14 days

  3. Cost effectiveness

    Cost effectiveness will be evaluated by comparing the total cost of treatment in both groups, including dressing materials, frequency of dressing changes, and overall management expenses during the study period.

    Time frame: 14 days

07

Study locations

1 site
  • UCHSLahore
    Lahore, Punjab Province 54000, Pakistan
08

References and documents

Publications

  • Shahzad MN, Ahmed N. Effectiveness of Aloe Vera gel compared with 1% silver sulphadiazine cream as burn wound dressing in second degree burns. J Pak Med Assoc. 2013 Feb;63(2):225-30. PubMed 23894900 ↗

Individual participant data

Plan to share: No — Pediatric patient data is sensitive Requires strict ethical approval for sharing Most single-center academic RCTs in Pakistan do not share IPD publicly

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Mar 2026, 12 months.

Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 12 months is below that.

Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2026
First posted
Jul 21, 2026
StartActual
Feb 20, 2025
Primary completionActual
Mar 15, 2026
CompletionActual
Mar 15, 2026
Last update
Jul 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07716605
Lead sponsor
University of Child Health Sciences and Children's Hospital, Lahore
Responsible party
Muhammad farrukh ahmad (Post Graduate Resident, University of Child Health Sciences and Children's Hospital, Lahore) — Principal investigator
First posted
Jul 21, 2026
Start date
Feb 20, 2025
Primary completion
Mar 15, 2026
Completion
Mar 15, 2026
Last update
Jul 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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