Acne VulgarisPhase 3NCT03071549
Combined Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Acne
A Phase 3 study testing Trichloroacetic acid peel and combined azaleic and salicylic acids in people with Acne Vulgaris, run by Cairo University.
Trial summary
Acne patients were included in this randomized controlled trial. Each patient received four treatment sessions two weeks apart. 20% azelaic acid combined with 20% salicylic acid were applied to the one side of the face while 25% trichloroacetic acid was applied to the other side. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Trichloroacetic acid peel and combined azaleic and salicylic acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Nov 2016
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any patients with active acne
Who cannot join
- Pregnancy.
- History of oral herpes simplex virus.
- History of keloid formation.
- Associated autoimmune disease (e.g vitiligo, systemic lupus erythematosus).
- History of past medications in the last six months.
- Patient unable to perform necessary postoperative care
About this study
Official title: Clinical and Dermoscopic Study Using a Combination of Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Mild to Moderate Acne , A Split Face, Double Blinded, Randomised Controlled Trial
Acne patients were included in this randomized controlled trial. Each patient received four treatment sessions two weeks apart. 20% azelaic acid combined with 20% salicylic acid were applied to the one side of the face while 25% trichloroacetic acid was applied to the other side. Evaluation was done by counting number of non-inflammatory and inflammatory lesions before, after two and after four treatment sessions. The dermoscope was used in evaluating the degree of improvement of erythema.
Read the detailed description
This study included 34 patients with mild and moderate acne vulgaris. The patients were recruited from the dermatology outpatient clinic of Kasr AlAiny hospital.
This study was approved by the Ethical committee of the Faculty of Medicine Cairo University and the Ethical committee of the Dermatology department Cairo University.
After signing an informed consent, patients were subjected to history taking, clinical examination and grading of their acne by global acne grading score, photography, dermoscopic examination and chemical peeling.
Photography:
Patient was photographed from front, lateral and side view before each session and two weeks after the 4th session. All photographs were taken using a digital camera (Nikon AW1, Indonesia) with identical lightening and patient positions.
Dermoscopy:
The cheek was split as four quadrants and photography of dermoscopic figures was taken before every session and two weeks after the 4th session (Using Dermalite DL3N Gen, USA).
Chemical peeling:
Skin degreasing was performed before every session using acetone. Trichloroacetic acid 25% was applied on one side of the face and azaleic acid 20% with salicylic acid 20% to the other side of the face randomly. Randomization was done through a computer-generated random sequence prepared by a statistician; Allocation was concealed in sequentially numbered, sealed, opaque envelopes, and kept by a nurse not involved in the study.
A gauze was used to apply the peel. The gauze was soaked with the peel. The peel was applied uniformly starting from medial to lateral. The peel was left on each side for around 60 seconds. The patients were asked to wash their faces using tape water for neutralization of the peel until the burning sensation is eliminated.
Patients received 4 sessions 2 weeks apart. As a post procedure care, the patients were asked to apply sun screens immediately after the procedure until their next session.
No other topical or systemic treatment was used during sessions. Patients will receive 4 peeling sessions 2 weeks apart.
- Conditions
- Acne Vulgaris
- Being tested
- Trichloroacetic acid peel, combined azaleic and salicylic acids
- Keywords
- Acne vulgaris, Chemical peeling, Dermoscopy
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichloroacetic acid peelDrug
Skin degreasing will be performed before every session using acetone. Trichloroacetic acid 25% will be applied on one side of the face.
combined azaleic and salicylic acidsDrug
Skin degreasing will be performed before every session using acetone. Azaleic acid 20% with salicylic acid 20% will be applied to the other side of the face.
| Study group | Role | What they receive |
|---|---|---|
| combined azaleic and salicylic acids | Active comparator | Combined azaleic acid 20% with salicylic acid 20% peel every 2 weeks for 4 sessions Receives: Drug: combined azaleic and salicylic acids |
| Trichloroacetic acid peel | Active comparator | Trichloroacetic acid 25% peel every 2 weeks for 4 sessions Receives: Drug: Trichloroacetic acid peel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acne lesions count
Change from baseline inflammatory and non-inflammatory lesions count at 2 months
Measured: 8 weeks
Secondary outcomes (1)
change in acne erythema grading
Change from baseline acne erythema grading using dermoscopy at 2 months
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startApr 2016
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Abdel hay, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071549
- Sponsor's protocol ID
- Dermatology REC 3/2016
- Status last verified
- Mar 2017
- First submitted
- 26 Feb 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Dermoscopic Study Using a Combination of Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Mild to Moderate Acne , A Split Face, Double Blinded, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03071549
- Acronym / sponsor ID
- Dermatology REC 3/2016
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, Chemical peeling, Dermoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Mar 2017 (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.
Acne patients were included in this randomized controlled trial. Each patient received four treatment sessions two weeks apart. 20% azelaic acid combined with 20% salicylic acid were applied to the one side of the face while 25% trichloroacetic acid was applied to the other side. Evaluation was done by counting number of non-inflammatory and inflammatory lesions before, after two and after four treatment sessions. The dermoscope was used in evaluating the degree of improvement of erythema.
Detailed description
This study included 34 patients with mild and moderate acne vulgaris. The patients were recruited from the dermatology outpatient clinic of Kasr AlAiny hospital.
This study was approved by the Ethical committee of the Faculty of Medicine Cairo University and the Ethical committee of the Dermatology department Cairo University.
After signing an informed consent, patients were subjected to history taking, clinical examination and grading of their acne by global acne grading score, photography, dermoscopic examination and chemical peeling.
Photography:
Patient was photographed from front, lateral and side view before each session and two weeks after the 4th session. All photographs were taken using a digital camera (Nikon AW1, Indonesia) with identical lightening and patient positions.
Dermoscopy:
The cheek was split as four quadrants and photography of dermoscopic figures was taken before every session and two weeks after the 4th session (Using Dermalite DL3N Gen, USA).
Chemical peeling:
Skin degreasing was performed before every session using acetone. Trichloroacetic acid 25% was applied on one side of the face and azaleic acid 20% with salicylic acid 20% to the other side of the face randomly. Randomization was done through a computer-generated random sequence prepared by a statistician; Allocation was concealed in sequentially numbered, sealed, opaque envelopes, and kept by a nurse not involved in the study.
A gauze was used to apply the peel. The gauze was soaked with the peel. The peel was applied uniformly starting from medial to lateral. The peel was left on each side for around 60 seconds. The patients were asked to wash their faces using tape water for neutralization of the peel until the burning sensation is eliminated.
Patients received 4 sessions 2 weeks apart. As a post procedure care, the patients were asked to apply sun screens immediately after the procedure until their next session.
No other topical or systemic treatment was used during sessions. Patients will receive 4 peeling sessions 2 weeks apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| combined azaleic and salicylic acids | Active comparator | Drug: combined azaleic and salicylic acidsCombined azaleic acid 20% with salicylic acid 20% peel every 2 weeks for 4 sessions |
| Trichloroacetic acid peel | Active comparator | Drug: Trichloroacetic acid peelTrichloroacetic acid 25% peel every 2 weeks for 4 sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patients with active acne
Key exclusion criteria (6 listed)
- Pregnancy.
- History of oral herpes simplex virus.
- History of keloid formation.
- Associated autoimmune disease (e.g vitiligo, systemic lupus erythematosus).
- History of past medications in the last six months.
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 |
|---|---|---|
| Trichloroacetic acid peelSkin degreasing will be performed before every session using acetone. Trichloroacetic acid 25% will be applied on one side of the face. | Drug | Trichloroacetic acid peel |
| combined azaleic and salicylic acidsSkin degreasing will be performed before every session using acetone. Azaleic acid 20% with salicylic acid 20% will be applied to the other side of the face. | Drug | combined azaleic and salicylic acids |
Primary outcome
Change in acne lesions count
Time frame: 8 weeks
Change from baseline inflammatory and non-inflammatory lesions count at 2 months
1 secondary outcome
change in acne erythema grading
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trichloroacetic acid peel and combined azaleic and salicylic acids in people with Acne Vulgaris, run by Cairo University.
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 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: finished, as of the sponsor's last update on 7 Mar 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in acne lesions count (time frame: 8 weeks). 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 7 Mar 2017.