PhotoagingNCT05004909
Effectivity of 1 Finger Tip Unit Compared to 2 Finger Tip Units 0.05% Tretinoin Cream
A study testing 0.05% Tretinoin in people with Photoaging, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
Trial summary
This clinical study will compare the efficacy of using one fingertip unit and two fingertip units of 0.05% before and after 30% trichloroacetic acid chemical peel procedure for facial skin rejuvenation in 35-60 years old female patients with Glogau II-III skin classification. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- 0.05% Tretinoin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2021to 31 Jan 2022
- Phase
- Interventional
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients aged 35-60 years old
- Patients with Glogau II-III skin classification
- Patients are willing to participate in the study and sign an informed consent form
Who cannot join
- Patients with hypertrophic scars or keloid on the face
- Patients with open wound or infection on the face
- History of other topical treatment on the face within 1 month of enrollment
- Pregnant or breastfeeding mother
- Patients and/or their families are not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Indonesia dr. Cipto Mangunkusumo Hospital
Jakarta, Jakarta Pusat, 10430
About this study
Official title: Effectivity of 1 Finger Tip Unit Compared to 2 Finger Tip Units 0.05% Tretinoin Cream Before and After 30% Trichloroacetic Acid Chemical Peeling on Aging Skin
This clinical study will compare the efficacy of using one fingertip unit and two fingertip units of 0.05% before and after 30% trichloroacetic acid chemical peel procedure for facial skin rejuvenation in 35-60 years old female patients with Glogau II-III skin classification.
Read the detailed description
This study is an experimental study with a randomized controlled trial (RCT) design on patients who met the inclusion criteria. Group A will receive pretreatment in the form of 0.05% tretinoin cream which is used as much as one fingertip unit every night, and group B will receive the same cream which should be used as much as two fingertip units. This cream will be used for two weeks before the patients receive a chemical peeling therapy using 30% trichloroacetic acid. The results of therapy will mainly be assessed based on the Dermoscopic Photoaging Scale (DPAS), as well as visual analog scale (VAS) for subjective symptoms and Clinician Erythema Assessment Scale (CEA) for erythema.
- Conditions
- Photoaging
- Being tested
- 0.05% Tretinoin
- Keywords
- Photoaging, Tretinoin, Trichloroacetic Acid, Chemical Peeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05% TretinoinDrug
Topical 0.05% tretinoin cream applied daily every night by the subjects according to assigned randomization
| Study group | Role | What they receive |
|---|---|---|
| 1 Fingertip Unit 0.05% Tretinoin | Active comparator | Subjects were randomized to receive the instructions to use 1 fingertip unit of 0.05% tretinoin cream for 2 weeks before the first chemical peeling. After that, this therapy is instructed to be used for 4 weeks after the chemical peeling procedure with 30% trichloroacetic acid until the scheduled evaluation. Receives: Drug: 0.05% Tretinoin |
| 2 Fingertip Units 0.05% Tretinoin | Experimental | Subjects were randomized to receive the instructions to use 2 fingertip units of 0.05% tretinoin cream for 2 weeks before the first chemical peeling. After that, this therapy is instructed to be used for 4 weeks after the chemical peeling procedure with 30% trichloroacetic acid until the scheduled evaluation. Receives: Drug: 0.05% Tretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Photoaged Skin Condition
using dermoscopic photoaging scale (DPAS). This DPAS assessment is based on yes or no rules on 11 criteria in four facial regions, namely left malar, right malar, forehead, and chin. The criteria were yellowish discoloration, white line, lentigo, hypo- and hyper-pigmented macules, telangiectasia, yellow papules, actinic keratosis, senile comedones, deep wrinkle, superficial wrinkle, and criss-cross wrinkle. Score range is 0-44 points.
Measured: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
Change of Subjective Pain Evaluation
using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain
Measured: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
Change of Erythema Degree
using Clinician Erythema Assessment Scale (CEA). Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema
Measured: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
Change in Skin Thickness
Evaluation with USG of epidermal and dermal layer (in pixels)
Measured: Baseline(pre-chemical peeling procedure) and 4 weeks after chemical peeling procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
- Investigators
- Irma BS Sitohang, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004909
- Sponsor's protocol ID
- TretandTCAPeeling
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2021
- Last updated
- 13 Aug 2021
- 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 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of 1 Finger Tip Unit Compared to 2 Finger Tip Units 0.05% Tretinoin Cream Before and After 30% Trichloroacetic Acid Chemical Peeling on Aging Skin
- ClinicalTrials.gov ID
- NCT05004909
- Acronym / sponsor ID
- TretandTCAPeeling
- Conditions
- Photoaging
- Keywords
- Photoaging, Tretinoin, Trichloroacetic Acid, Chemical Peeling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 13 Aug 2021 (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 clinical study will compare the efficacy of using one fingertip unit and two fingertip units of 0.05% before and after 30% trichloroacetic acid chemical peel procedure for facial skin rejuvenation in 35-60 years old female patients with Glogau II-III skin classification.
Detailed description
This study is an experimental study with a randomized controlled trial (RCT) design on patients who met the inclusion criteria. Group A will receive pretreatment in the form of 0.05% tretinoin cream which is used as much as one fingertip unit every night, and group B will receive the same cream which should be used as much as two fingertip units. This cream will be used for two weeks before the patients receive a chemical peeling therapy using 30% trichloroacetic acid. The results of therapy will mainly be assessed based on the Dermoscopic Photoaging Scale (DPAS), as well as visual analog scale (VAS) for subjective symptoms and Clinician Erythema Assessment Scale (CEA) for erythema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Fingertip Unit 0.05% Tretinoin | Active comparator | Drug: 0.05% TretinoinSubjects were randomized to receive the instructions to use 1 fingertip unit of 0.05% tretinoin cream for 2 weeks before the first chemical peeling. After that, this therapy is instructed to be used for 4 weeks after the chemical peeling procedure with 30% trichloroacetic acid until the scheduled evaluation. |
| 2 Fingertip Units 0.05% Tretinoin | Experimental | Drug: 0.05% TretinoinSubjects were randomized to receive the instructions to use 2 fingertip units of 0.05% tretinoin cream for 2 weeks before the first chemical peeling. After that, this therapy is instructed to be used for 4 weeks after the chemical peeling procedure with 30% trichloroacetic acid until the scheduled evaluation. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients aged 35-60 years old
- Patients with Glogau II-III skin classification
- Patients are willing to participate in the study and sign an informed consent form
Key exclusion criteria (5 listed)
- Patients with hypertrophic scars or keloid on the face
- Patients with open wound or infection on the face
- History of other topical treatment on the face within 1 month of enrollment
- Pregnant or breastfeeding mother
- Patients and/or their families are not willing to participate in the study.
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 |
|---|---|---|
| 0.05% TretinoinTopical 0.05% tretinoin cream applied daily every night by the subjects according to assigned randomization | Drug | 1 Fingertip Unit 0.05% Tretinoin, 2 Fingertip Units 0.05% Tretinoin |
Primary outcome
Change of Photoaged Skin Condition
Time frame: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
using dermoscopic photoaging scale (DPAS). This DPAS assessment is based on yes or no rules on 11 criteria in four facial regions, namely left malar, right malar, forehead, and chin. The criteria were yellowish discoloration, white line, lentigo, hypo- and hyper-pigmented macules, telangiectasia, yellow papules, actinic keratosis, senile comedones, deep wrinkle, superficial wrinkle, and criss-cross wrinkle. Score range is 0-44 points.
Change of Subjective Pain Evaluation
Time frame: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain
Change of Erythema Degree
Time frame: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
using Clinician Erythema Assessment Scale (CEA). Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema
Change in Skin Thickness
Time frame: Baseline(pre-chemical peeling procedure) and 4 weeks after chemical peeling procedure
Evaluation with USG of epidermal and dermal layer (in pixels)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- 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.
Irma BS Sitohang, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.05% Tretinoin in people with Photoaging, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
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 3 inclusion and 5 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 13 Aug 2021. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irma BS Sitohang, MD (+62818130761, irma_bernadette@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Photoaged Skin Condition (time frame: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure). The study lists 4 primary outcomes in all. 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 13 Aug 2021.